Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-02-11 @ 3:24 PM
Study NCT ID:
NCT04200651
Status:
TERMINATED
Last Update Posted:
2024-01-31
First Post:
2019-12-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007905', 'term': 'Lens Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'C009935', 'term': 'prednisolone acetate'}, {'id': 'D008775', 'term': 'Methylprednisolone'}], 'ancestors': [{'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tannicholas97@gmail.com', 'phone': '3476175971', 'title': 'Dr. Nicholas Tan', 'organization': 'New York Eye Surgery Center; University of Colorado'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Early termination related to COVID-19 recruitment difficulties and loss to follow-up leading to small numbers of eyes analyzed. Length of follow-up limited to 3 months. Use of only three types of minimally invasive glaucoma surgery. Single-site, single-surgeon, open-label design.'}}, 'adverseEventsModule': {'timeFrame': 'From baseline visit through 3 months of follow-up, the final study visit', 'description': 'As mentioned previously in the results section, the number of eyes analyzed differs from the "started" row in Participant Flow Overview. Though 24 eyes were consented and met retention criteria, 6 eyes dropped out prior to complete baseline assessment and prior to surgery. Thus, there were 18 eyes "at risk" because only 18 eyes were operated on.', 'eventGroups': [{'id': 'EG000', 'title': 'DEXTENZA® Arm', 'description': "This arm will receive the DEXTENZA® insert after cataract surgery and MIGS.\n\nDexamethasone Ophthalmic Insert: DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen.", 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Prednisolone Acetate 1% Arm', 'description': 'This arm will receive the prescription for daily prednisolone acetate 1% eye drops after cataract surgery and MIGS.\n\nPrednisolone Acetate 1% Oph Susp: Prednisolone acetate 1% eye drops are used 2-4 times daily for 30 days as the current standard of care for treating inflammation and eye pain after cataract surgery. Prednisolone, like dexamethasone, is a steroid. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Eye pain with movement and lid twitching', 'notes': 'Eye pain with movement and right upper lid twitching that occurred on post-op day 7 and resolved with supplemental topical anti-inflammatory eye drops.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyphema and shallow iris', 'notes': '2mm hyphema and shallow iris that occurred on post-op day 1 and successfully resolved with topical atropine.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Floaters', 'notes': 'New-onset small floaters that were noted by the patient on post-op day 30, likely unrelated to the surgery or intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Intraocular Pressure (IOP) at 1 and 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DEXTENZA® Arm', 'description': "This arm will receive the DEXTENZA® insert after cataract surgery and MIGS.\n\nDexamethasone Ophthalmic Insert: DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen."}, {'id': 'OG001', 'title': 'Prednisolone Acetate 1% Arm', 'description': 'This arm will receive the prescription for daily prednisolone acetate 1% eye drops after cataract surgery and MIGS.\n\nPrednisolone Acetate 1% Oph Susp: Prednisolone acetate 1% eye drops are used 2-4 times daily for 30 days as the current standard of care for treating inflammation and eye pain after cataract surgery. Prednisolone, like dexamethasone, is a steroid. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen.'}], 'classes': [{'title': 'Change in IOP by Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.89', 'spread': '2.37', 'groupId': 'OG000'}, {'value': '-6.60', 'spread': '3.29', 'groupId': 'OG001'}]}]}, {'title': 'Change in IOP by Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.05', 'spread': '3.30', 'groupId': 'OG000'}, {'value': '-4.6', 'spread': '3.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month postop, 3 months postop', 'description': 'Using quantitative IOP readings to compare ocular safety between arms. Since the outcome examined was a "change," baseline, month 1 postop, and month 3 postop data were used in the calculations.\n\n1 month change calculation: Month 1 postop value - Baseline value 3 month change calculation: Month 3 postop value - Baseline value', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Change in IOP from baseline at months 1 and 3 were compared between groups.'}, {'type': 'PRIMARY', 'title': 'Change in Best-corrected Visual Acuity (BCVA) at 1 and 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DEXTENZA® Arm', 'description': "This arm will receive the DEXTENZA® insert after cataract surgery and MIGS.\n\nDexamethasone Ophthalmic Insert: DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen."}, {'id': 'OG001', 'title': 'Prednisolone Acetate 1% Arm', 'description': 'This arm will receive the prescription for daily prednisolone acetate 1% eye drops after cataract surgery and MIGS.\n\nPrednisolone Acetate 1% Oph Susp: Prednisolone acetate 1% eye drops are used 2-4 times daily for 30 days as the current standard of care for treating inflammation and eye pain after cataract surgery. Prednisolone, like dexamethasone, is a steroid. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen.'}], 'classes': [{'title': 'LogMAR change by Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.60', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'LogMAR change by Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.53', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '0.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month postop, 3 months postop', 'description': 'Using quantitative BCVA measurements, as determined by ETDRS chart at 4 meters, to compare ocular safety and effectiveness between arms. Since the outcome examined was a "change," baseline, month 1 postop, and month 3 postop data were used in the calculations.\n\n1 month change calculation: Month 1 postop value - Baseline value 3 month change calculation: Month 3 postop value - Baseline value', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'LogMAR visual acuity changes from baseline to months 1 and 3 were compared between groups. Please note that for logMAR, lower values on the scale correspond with better visual acuity.'}, {'type': 'PRIMARY', 'title': 'Difference in Eyes With Adverse Events Between Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DEXTENZA® Arm', 'description': "This arm will receive the DEXTENZA® insert after cataract surgery and MIGS.\n\nDexamethasone Ophthalmic Insert: DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen."}, {'id': 'OG001', 'title': 'Prednisolone Acetate 1% Arm', 'description': 'This arm will receive the prescription for daily prednisolone acetate 1% eye drops after cataract surgery and MIGS.\n\nPrednisolone Acetate 1% Oph Susp: Prednisolone acetate 1% eye drops are used 2-4 times daily for 30 days as the current standard of care for treating inflammation and eye pain after cataract surgery. Prednisolone, like dexamethasone, is a steroid. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 months postop', 'description': 'Using the average number of eyes with adverse events that occur in each arm to compare safety between arms through 3 months of postoperative follow-up', 'unitOfMeasure': 'Number of eyes with adverse events', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'PRIMARY', 'title': 'Difference in Number of Glaucoma Medications at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DEXTENZA® Arm', 'description': "This arm will receive the DEXTENZA® insert after cataract surgery and MIGS.\n\nDexamethasone Ophthalmic Insert: DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen."}, {'id': 'OG001', 'title': 'Prednisolone Acetate 1% Arm', 'description': 'This arm will receive the prescription for daily prednisolone acetate 1% eye drops after cataract surgery and MIGS.\n\nPrednisolone Acetate 1% Oph Susp: Prednisolone acetate 1% eye drops are used 2-4 times daily for 30 days as the current standard of care for treating inflammation and eye pain after cataract surgery. Prednisolone, like dexamethasone, is a steroid. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.45', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '-0.60', 'spread': '0.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months postop', 'description': 'Using the average number of glaucoma medications added or subtracted to each arm to compare safety between arms. These calculations were performed by subtracting the baseline glaucoma medications from the glaucoma medications at month 3.', 'unitOfMeasure': 'number of medications', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Change in number of glaucoma medications between groups from baseline to month 3 were compared.'}, {'type': 'SECONDARY', 'title': 'Percentage of Eyes Requiring Supplemental Prednisolone Acetate 1% Eye Drops', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}, {'units': 'Eyes', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DEXTENZA® Arm', 'description': "This arm will receive the DEXTENZA® insert after cataract surgery and MIGS.\n\nDexamethasone Ophthalmic Insert: DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen."}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 months postop', 'description': 'Recording the percentage of eyes in the DEXTENZA® arm that require anti-inflammatory rescue with supplemental ocular steroid. This will provide insight into anti-inflammatory effectiveness of DEXTENZA®', 'unitOfMeasure': 'Percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Of the 14 consented eyes in the DEXTENZA arm noted in the "started" row of the participant flow data table, 2 eyes met exclusion criteria, thus leaving 12 eligible eyes for further analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Eyes With Presenting With Cystoid Macular Edema (CME) as Seen on Optical Coherence Tomography (OCT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DEXTENZA® Arm', 'description': "This arm will receive the DEXTENZA® insert after cataract surgery and MIGS.\n\nDexamethasone Ophthalmic Insert: DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen."}, {'id': 'OG001', 'title': 'Prednisolone Acetate 1% Arm', 'description': 'This arm will receive the prescription for daily prednisolone acetate 1% eye drops after cataract surgery and MIGS.\n\nPrednisolone Acetate 1% Oph Susp: Prednisolone acetate 1% eye drops are used 2-4 times daily for 30 days as the current standard of care for treating inflammation and eye pain after cataract surgery. Prednisolone, like dexamethasone, is a steroid. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '3 months postop', 'description': 'Using the number of CME cases in each arm, as visualized by OCT, to compare safety and effectiveness between arms', 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Difference in Ocular Comfort Index (OCI) Score at 1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DEXTENZA® Arm', 'description': "This arm will receive the DEXTENZA® insert after cataract surgery and MIGS.\n\nDexamethasone Ophthalmic Insert: DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen."}, {'id': 'OG001', 'title': 'Prednisolone Acetate 1% Arm', 'description': 'This arm will receive the prescription for daily prednisolone acetate 1% eye drops after cataract surgery and MIGS.\n\nPrednisolone Acetate 1% Oph Susp: Prednisolone acetate 1% eye drops are used 2-4 times daily for 30 days as the current standard of care for treating inflammation and eye pain after cataract surgery. Prednisolone, like dexamethasone, is a steroid. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.96', 'spread': '12.50', 'groupId': 'OG000'}, {'value': '10.71', 'spread': '15.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month postop', 'description': "Using the Ocular Comfort Index survey to compare patients' self-reported ocular comfort between arms, providing insight into drug effectiveness. The minimum score is 0 and the maximum score is 100, with 100 indicating the most ocular irritation and discomfort and 0 indicating the least ocular irritation and discomfort", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Scores were compared between groups at month 1. Higher scores correspond to greater ocular discomfort. Of the 18 eyes that received baseline analysis and surgery, only 10 completed the month 1 OCI survey.'}, {'type': 'SECONDARY', 'title': 'Difference in Ocular Comfort Index (OCI) Score at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DEXTENZA® Arm', 'description': "This arm will receive the DEXTENZA® insert after cataract surgery and MIGS.\n\nDexamethasone Ophthalmic Insert: DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen."}, {'id': 'OG001', 'title': 'Prednisolone Acetate 1% Arm', 'description': 'This arm will receive the prescription for daily prednisolone acetate 1% eye drops after cataract surgery and MIGS.\n\nPrednisolone Acetate 1% Oph Susp: Prednisolone acetate 1% eye drops are used 2-4 times daily for 30 days as the current standard of care for treating inflammation and eye pain after cataract surgery. Prednisolone, like dexamethasone, is a steroid. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.20', 'spread': '14.67', 'groupId': 'OG000'}, {'value': '16.32', 'spread': '16.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months postop', 'description': "Using the Ocular Comfort Index survey to compare patients' self-reported ocular comfort between arms, providing insight into drug effectiveness. The minimum score is 0 and the maximum score is 100, with 100 indicating the most ocular irritation and discomfort and 0 indicating the least ocular irritation and discomfort", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Scores were compared between groups at month 3. Higher scores correspond to greater ocular discomfort.'}, {'type': 'SECONDARY', 'title': 'Difference in Number of Eyes With Absence of Anterior Chamber (AC) Cells at 1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DEXTENZA® Arm', 'description': "This arm will receive the DEXTENZA® insert after cataract surgery and MIGS.\n\nDexamethasone Ophthalmic Insert: DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen."}, {'id': 'OG001', 'title': 'Prednisolone Acetate 1% Arm', 'description': 'This arm will receive the prescription for daily prednisolone acetate 1% eye drops after cataract surgery and MIGS.\n\nPrednisolone Acetate 1% Oph Susp: Prednisolone acetate 1% eye drops are used 2-4 times daily for 30 days as the current standard of care for treating inflammation and eye pain after cataract surgery. Prednisolone, like dexamethasone, is a steroid. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '1 month postop', 'description': 'Comparing the number of eyes with complete AC clearance of inflammatory cells, as determined by slit lamp exam, between arms to evaluate drug effectiveness', 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Counts indicate the number of eyes with no AC cell or flare present at 1 month follow-up.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DEXTENZA® Arm', 'description': "This arm will receive the DEXTENZA® insert after cataract surgery and MIGS.\n\nDexamethasone Ophthalmic Insert: DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen."}, {'id': 'FG001', 'title': 'Prednisolone Acetate 1% Arm', 'description': 'This arm will receive the prescription for daily prednisolone acetate 1% eye drops after cataract surgery and MIGS.\n\nPrednisolone Acetate 1% Oph Susp: Prednisolone acetate 1% eye drops are used 2-4 times daily for 30 days as the current standard of care for treating inflammation and eye pain after cataract surgery. Prednisolone, like dexamethasone, is a steroid. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '14', 'numSubjects': '14'}, {'groupId': 'FG001', 'numUnits': '10', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '11', 'numSubjects': '11'}, {'groupId': 'FG001', 'numUnits': '5', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '3'}, {'groupId': 'FG001', 'numUnits': '5', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Moved to another country during follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'typeUnitsAnalyzed': 'Eyes', 'preAssignmentDetails': 'In total, 25 subjects contributing 29 eyes were consented for the study. Of those 29 eyes consented, 5 eyes from 5 subjects met exclusion criteria, thus leaving 24 eyes from 20 subjects who started the study as described below.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DEXTENZA® Arm', 'description': "This arm will receive the DEXTENZA® insert after cataract surgery and MIGS.\n\nDexamethasone Ophthalmic Insert: DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen."}, {'id': 'BG001', 'title': 'Prednisolone Acetate 1% Arm', 'description': 'This arm will receive the prescription for daily prednisolone acetate 1% eye drops after cataract surgery and MIGS.\n\nPrednisolone Acetate 1% Oph Susp: Prednisolone acetate 1% eye drops are used 2-4 times daily for 30 days as the current standard of care for treating inflammation and eye pain after cataract surgery. Prednisolone, like dexamethasone, is a steroid. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Single eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '70.6', 'spread': '11.65', 'groupId': 'BG000'}, {'value': '73', 'spread': '6.32', 'groupId': 'BG001'}, {'value': '71.3', 'spread': '10.22', 'groupId': 'BG002'}]}]}, {'title': 'Fellow eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '67', 'spread': '9.90', 'groupId': 'BG000'}, {'value': '67', 'spread': '9.90', 'groupId': 'BG001'}, {'value': '67', 'spread': '8.08', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Rows have been split into single eyes (eyes from individual participants) and fellow-eyes (eyes from the same participants).'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Single eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Fellow eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Rows have been split into single eyes (eyes from individual participants) and fellow-eyes (eyes from the same participants).'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Single eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Hispanic/Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Fellow eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Hispanic/Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Rows have been split into single eyes (eyes from individual participants) and fellow-eyes (eyes from the same participants).'}, {'title': 'Region of Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'title': 'Prior glaucoma laser treatment', 'classes': [{'title': 'Single eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Fellow eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Rows have been split into single eyes (eyes from individual participants) and fellow-eyes (eyes from the same participants).'}, {'title': 'Minimally invasive glaucoma surgery (MIGS) type', 'classes': [{'title': 'Single eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hydrus', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'iStent', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Canaloplasty', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Fellow eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hydrus', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'iStent', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Canaloplasty', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Rows have been split into single eyes (eyes from individual participants) and fellow-eyes (eyes from the same participants).'}, {'title': 'Glaucoma severity', 'classes': [{'title': 'Single eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Mild glaucoma', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Moderate glaucoma', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Fellow eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Mild glaucoma', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Moderate glaucoma', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Rows have been split into single eyes (eyes from individual participants) and fellow-eyes (eyes from the same participants).'}, {'title': 'Intraocular pressure (IOP)', 'classes': [{'title': 'Single eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '17.75', 'spread': '1.96', 'groupId': 'BG000'}, {'value': '18.75', 'spread': '4.86', 'groupId': 'BG001'}, {'value': '18.04', 'spread': '2.89', 'groupId': 'BG002'}]}]}, {'title': 'Fellow eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '16', 'spread': '5.66', 'groupId': 'BG000'}, {'value': '16', 'spread': '5.66', 'groupId': 'BG001'}, {'value': '16', 'spread': '4.62', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Rows have been split into single eyes (eyes from individual participants) and fellow-eyes (eyes from the same participants).'}, {'title': 'LogMAR visual acuity', 'classes': [{'title': 'Single eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.83', 'spread': '0.68', 'groupId': 'BG000'}, {'value': '0.58', 'spread': '0.30', 'groupId': 'BG001'}, {'value': '0.76', 'spread': '0.60', 'groupId': 'BG002'}]}]}, {'title': 'Fellow eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.03', 'groupId': 'BG000'}, {'value': '0.47', 'spread': '0.10', 'groupId': 'BG001'}, {'value': '0.50', 'spread': '0.07', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'logMAR', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Rows have been split into single eyes (eyes from individual participants) and fellow-eyes (eyes from the same participants).'}, {'title': 'Central corneal thickness', 'classes': [{'title': 'Single eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '521.70', 'spread': '39.88', 'groupId': 'BG000'}, {'value': '534.80', 'spread': '23.39', 'groupId': 'BG001'}, {'value': '525.44', 'spread': '35.57', 'groupId': 'BG002'}]}]}, {'title': 'Fellow eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '492', 'spread': '5.66', 'groupId': 'BG000'}, {'value': '475', 'spread': '4.24', 'groupId': 'BG001'}, {'value': '483.5', 'spread': '10.63', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'microns', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Rows have been split into single eyes (eyes from individual participants) and fellow-eyes (eyes from the same participants).'}, {'title': 'Retinal nerve fiber layer (RNFL) thickness', 'classes': [{'title': 'Single eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '72.9', 'spread': '11.73', 'groupId': 'BG000'}, {'value': '75.75', 'spread': '17.29', 'groupId': 'BG001'}, {'value': '73.71', 'spread': '12.89', 'groupId': 'BG002'}]}]}, {'title': 'Fellow eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '53.5', 'spread': '7.78', 'groupId': 'BG000'}, {'value': '75', 'spread': '2.83', 'groupId': 'BG001'}, {'value': '64.25', 'spread': '13.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'microns', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Rows have been split into single eyes (eyes from individual participants) and fellow-eyes (eyes from the same participants).'}, {'title': 'Cup-to-disc ratio', 'classes': [{'title': 'Single eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.65', 'spread': '0.09', 'groupId': 'BG000'}, {'value': '0.67', 'spread': '0.07', 'groupId': 'BG001'}, {'value': '0.66', 'spread': '0.08', 'groupId': 'BG002'}]}]}, {'title': 'Fellow eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.63', 'spread': '0.21', 'groupId': 'BG000'}, {'value': '0.49', 'spread': '0.20', 'groupId': 'BG001'}, {'value': '0.56', 'spread': '0.19', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Anatomic ratio of cup size to disc size as determined on exam, with larger ratios generally correlating with glaucoma severity', 'unitOfMeasure': 'ratio', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Rows have been split into single eyes (eyes from individual participants) and fellow-eyes (eyes from the same participants).'}, {'title': 'Glaucoma medications', 'classes': [{'title': 'Single eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.92', 'groupId': 'BG000'}, {'value': '1.5', 'spread': '0.58', 'groupId': 'BG001'}, {'value': '1.7', 'spread': '0.83', 'groupId': 'BG002'}]}]}, {'title': 'Fellow eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'spread': '0', 'groupId': 'BG000'}, {'value': '1', 'spread': '0', 'groupId': 'BG001'}, {'value': '1', 'spread': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'medications', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Rows have been split into single eyes (eyes from individual participants) and fellow-eyes (eyes from the same participants).'}, {'title': 'Visual field mean deviation (VFMD)', 'classes': [{'title': 'Single eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '-8.45', 'spread': '4.31', 'groupId': 'BG000'}, {'value': '-4.20', 'spread': '4.89', 'groupId': 'BG001'}, {'value': '-7.24', 'spread': '4.73', 'groupId': 'BG002'}]}]}, {'title': 'Fellow eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '-4.74', 'spread': 'NA', 'comment': 'n=1 for VFMD in this group', 'groupId': 'BG000'}, {'value': '-2.55', 'spread': 'NA', 'comment': 'n=1 for VFMD in this group', 'groupId': 'BG001'}, {'value': '-3.65', 'spread': '1.10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "VFMD is an aggregate measure of one's visual field deficits obtained on the Humphrey Visual Field 24-2 algorithm. Generally, more negative values correlate with worse deficits", 'unitOfMeasure': 'dB', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Rows have been split into single eyes (eyes from individual participants) and fellow-eyes (eyes from the same participants).'}], 'typeUnitsAnalyzed': 'Eyes', 'populationDescription': '24 eyes from 20 subjects were consented and met criteria for the study (see Participant Flow Overview). However, prior to full baseline assessment and prior to surgery, 6 eyes from 4 subjects dropped out, leaving 18 eyes from 16 subjects. Additionally, given that a mixed-eye sample can impact statistical assumptions of independence, baseline data comparisons were separated between single eyes and fellow-eyes.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-18', 'size': 337776, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-10T17:55', 'hasProtocol': True}, {'date': '2020-10-20', 'size': 197898, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-11-10T17:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This prospective study enrolled 29 eyes from 25 total patients. The protocol permitted some binocular enrollment from patients who met eligibility criteria in both eyes.\n\nAll eligible eyes received concomitant cataract and MIGS surgery. Each eye was randomized to receive either DEXTENZA® insertion at the end of the surgery or to a standard of care prednisolone acetate 1% eye drop regimen via block randomization. All eyes received the standard of care topical ofloxacin antibiotic regimen. The experimental group consisted of the eyes receiving DEXTENZA® insertion. The control group consisted of the eyes placed on the prednisolone eye drop regimen.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'whyStopped': 'COVID-19 challenges to recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-07', 'studyFirstSubmitDate': '2019-12-12', 'resultsFirstSubmitDate': '2023-11-13', 'studyFirstSubmitQcDate': '2019-12-12', 'lastUpdatePostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-07', 'studyFirstPostDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Intraocular Pressure (IOP) at 1 and 3 Months', 'timeFrame': '1 month postop, 3 months postop', 'description': 'Using quantitative IOP readings to compare ocular safety between arms. Since the outcome examined was a "change," baseline, month 1 postop, and month 3 postop data were used in the calculations.\n\n1 month change calculation: Month 1 postop value - Baseline value 3 month change calculation: Month 3 postop value - Baseline value'}, {'measure': 'Change in Best-corrected Visual Acuity (BCVA) at 1 and 3 Months', 'timeFrame': '1 month postop, 3 months postop', 'description': 'Using quantitative BCVA measurements, as determined by ETDRS chart at 4 meters, to compare ocular safety and effectiveness between arms. Since the outcome examined was a "change," baseline, month 1 postop, and month 3 postop data were used in the calculations.\n\n1 month change calculation: Month 1 postop value - Baseline value 3 month change calculation: Month 3 postop value - Baseline value'}, {'measure': 'Difference in Eyes With Adverse Events Between Groups', 'timeFrame': 'Up to 3 months postop', 'description': 'Using the average number of eyes with adverse events that occur in each arm to compare safety between arms through 3 months of postoperative follow-up'}, {'measure': 'Difference in Number of Glaucoma Medications at 3 Months', 'timeFrame': '3 months postop', 'description': 'Using the average number of glaucoma medications added or subtracted to each arm to compare safety between arms. These calculations were performed by subtracting the baseline glaucoma medications from the glaucoma medications at month 3.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Eyes Requiring Supplemental Prednisolone Acetate 1% Eye Drops', 'timeFrame': 'Up to 3 months postop', 'description': 'Recording the percentage of eyes in the DEXTENZA® arm that require anti-inflammatory rescue with supplemental ocular steroid. This will provide insight into anti-inflammatory effectiveness of DEXTENZA®'}, {'measure': 'Number of Eyes With Presenting With Cystoid Macular Edema (CME) as Seen on Optical Coherence Tomography (OCT)', 'timeFrame': '3 months postop', 'description': 'Using the number of CME cases in each arm, as visualized by OCT, to compare safety and effectiveness between arms'}, {'measure': 'Difference in Ocular Comfort Index (OCI) Score at 1 Month', 'timeFrame': '1 month postop', 'description': "Using the Ocular Comfort Index survey to compare patients' self-reported ocular comfort between arms, providing insight into drug effectiveness. The minimum score is 0 and the maximum score is 100, with 100 indicating the most ocular irritation and discomfort and 0 indicating the least ocular irritation and discomfort"}, {'measure': 'Difference in Ocular Comfort Index (OCI) Score at 3 Months', 'timeFrame': '3 months postop', 'description': "Using the Ocular Comfort Index survey to compare patients' self-reported ocular comfort between arms, providing insight into drug effectiveness. The minimum score is 0 and the maximum score is 100, with 100 indicating the most ocular irritation and discomfort and 0 indicating the least ocular irritation and discomfort"}, {'measure': 'Difference in Number of Eyes With Absence of Anterior Chamber (AC) Cells at 1 Month', 'timeFrame': '1 month postop', 'description': 'Comparing the number of eyes with complete AC clearance of inflammatory cells, as determined by slit lamp exam, between arms to evaluate drug effectiveness'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MIGS, Minimally invasive glaucoma surgery'], 'conditions': ['Glaucoma', 'Cataract']}, 'referencesModule': {'references': [{'pmid': '17898265', 'type': 'BACKGROUND', 'citation': 'Johnson ME, Murphy PJ. Measurement of ocular surface irritation on a linear interval scale with the ocular comfort index. Invest Ophthalmol Vis Sci. 2007 Oct;48(10):4451-8. doi: 10.1167/iovs.06-1253.'}, {'pmid': '28670710', 'type': 'BACKGROUND', 'citation': 'Juthani VV, Clearfield E, Chuck RS. Non-steroidal anti-inflammatory drugs versus corticosteroids for controlling inflammation after uncomplicated cataract surgery. Cochrane Database Syst Rev. 2017 Jul 3;7(7):CD010516. doi: 10.1002/14651858.CD010516.pub2.'}, {'pmid': '29502618', 'type': 'BACKGROUND', 'citation': 'Kindle T, Ferguson T, Ibach M, Greenwood M, Schweitzer J, Swan R, Sudhagoni RG, Berdahl JP. Safety and efficacy of intravitreal injection of steroid and antibiotics in the setting of cataract surgery and trabecular microbypass stent. J Cataract Refract Surg. 2018 Jan;44(1):56-62. doi: 10.1016/j.jcrs.2017.10.040.'}, {'pmid': '25912144', 'type': 'BACKGROUND', 'citation': 'Newman-Casey PA, Robin AL, Blachley T, Farris K, Heisler M, Resnicow K, Lee PP. The Most Common Barriers to Glaucoma Medication Adherence: A Cross-Sectional Survey. Ophthalmology. 2015 Jul;122(7):1308-16. doi: 10.1016/j.ophtha.2015.03.026. Epub 2015 Apr 24.'}, {'pmid': '27486301', 'type': 'BACKGROUND', 'citation': 'Fisher BL, Potvin R. Transzonular vitreous injection vs a single drop compounded topical pharmaceutical regimen after cataract surgery. Clin Ophthalmol. 2016 Jul 18;10:1297-303. doi: 10.2147/OPTH.S112080. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': "In this study, the investigators are comparing dexamethasone ophthalmic insert (DEXTENZA®) to the current standard of care, prednisolone acetate 1% eye drops, in a glaucoma population receiving both cataract and minimally-invasive glaucoma surgery (MIGS). DEXTENZA® and prednisolone acetate 1% drops are both steroids used to control inflammation after eye surgery. DEXTENZA®'s method of delivery differs by offering a sustained release of steroid that does not necessitate postoperative anti-inflammatory eye drops. The investigators hypothesize that DEXTENZA® will be as safe as prednisolone acetate 1% drops and as effective at controlling postoperative inflammation following concomitant cataract-MIGS in a glaucoma population. The investigators also hypothesize that DEXTENZA® will be preferred by patients over prednisolone acetate 1% drops.", 'detailedDescription': 'Glaucoma and cataract surgery patients face an outsize postoperative burden. In addition to taking frequent anti-inflammatory eye drops, they often continue their glaucoma medications. This can cause patient confusion and nonadherence, potentially leading to poor healing, slower recovery period, and/or cystoid macular edema. DEXTENZA®, as a sustained release anti-inflammatory insert, could help preclude adherence difficulties and increase comfort by reducing eye drop load. However, glaucoma surgeons may hesitate to adopt DEXTENZA® due to concerns regarding safety with respect to elevated intraocular pressure. This prospective study will address those concerns directly, providing timely and high-quality clinical evidence comparing DEXTENZA® to standard-of-care steroid eye drops. For physicians and patients, the results of this study will prove immediately useful for therapeutic decision-making.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cataract surgery candidate and glaucoma present in at least one eye.\n* Minimally-invasive glaucoma surgery candidate in that same eye. Defined by having ocular hypertension requiring a medication, OR as by having mild, moderate, or severe glaucoma that is sufficiently stable and appropriate for operation.\n\nExclusion Criteria:\n\n* Maintains regular use (daily or more) of systemic or ocular steroids at time of enrollment\n* Maintains regular use (daily or more) of systemic or ocular nonsteroidal anti-inflammatory drugs at time of enrollment\n* Anterior chamber cells present at time of enrollment\n* Recent febrile illness that precludes or delays participation for 3 months\n* Pregnancy or lactation\n* Known allergy to dexamethasone\n* Known allergy to prednisolone\n* Treatment with another investigational drug within the last 20 years\n* Current recreational drug use\n* Preexisting ocular pathology likely to confound the visual acuity or comfort endpoints including but not limited to: severe corneal scarring, ocular surface disease, diabetic retinopathy, or macular edema\n* Corneal or retinal procedures (laser or incisional) during the study period and 6 months prior'}, 'identificationModule': {'nctId': 'NCT04200651', 'acronym': 'SUSTAIN', 'briefTitle': 'Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'The New York Eye Surgery Center'}, 'officialTitle': 'Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery', 'orgStudyIdInfo': {'id': '146602'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DEXTENZA® arm', 'description': 'This arm will receive the DEXTENZA® insert after cataract surgery and MIGS.', 'interventionNames': ['Drug: Dexamethasone Ophthalmic Insert']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prednisolone acetate 1% arm', 'description': 'This arm will receive the prescription for daily prednisolone acetate 1% eye drops after cataract surgery and MIGS.', 'interventionNames': ['Drug: Prednisolone Acetate 1% Oph Susp']}], 'interventions': [{'name': 'Dexamethasone Ophthalmic Insert', 'type': 'DRUG', 'otherNames': ['DEXTENZA®'], 'description': "DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen.", 'armGroupLabels': ['DEXTENZA® arm']}, {'name': 'Prednisolone Acetate 1% Oph Susp', 'type': 'DRUG', 'otherNames': ['PRED FORTE®, OMNIPRED®'], 'description': 'Prednisolone acetate 1% eye drops are used 2-4 times daily for 30 days as the current standard of care for treating inflammation and eye pain after cataract surgery. Prednisolone, like dexamethasone, is a steroid. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen.', 'armGroupLabels': ['Prednisolone acetate 1% arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10469', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'The New York Eye Surgery Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Nathan M Radcliffe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York Eye Surgery Center; New York Eye and Ear Infirmary of Mount Sinai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is not a plan to make IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The New York Eye Surgery Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ocular Therapeutix, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Nathan M. Radcliffe, Attending Ophthalmologist', 'investigatorFullName': 'Nathan M. Radcliffe, MD', 'investigatorAffiliation': 'The New York Eye Surgery Center'}}}}