Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-01-01 @ 4:19 AM
Study NCT ID:
NCT03864133
Status:
COMPLETED
Last Update Posted:
2023-11-30
First Post:
2019-02-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
No Drop Post-Op Cataract Surgery
Sponsor:
Organization:
Raw JSON
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The presence of CME will be determined clinically.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Macular Thickness Measurement - Number in Microns', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Omidria', 'description': 'Phenylephrine/Ketorolac (1%/0.3%) will be administered to all participants enrolled into the study.\n\nOmidria: Phenylephrine and Ketorolac infusion of 1%/0.3% during cataract surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 6', 'description': 'The thickness of the macula will be measured pre and post operatively using ocular imaging to determine if Omidria is sufficient in controlling thickening post-operatively - measured in number of Microns', 'unitOfMeasure': 'Number of Microns', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Needing NSAID Post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Omidria', 'description': 'Phenylephrine/Ketorolac (1%/0.3%) will be administered to all participants enrolled into the study.\n\nOmidria: Phenylephrine and Ketorolac infusion of 1%/0.3% during cataract surgery.'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-op weeks 1 through 6', 'description': 'Need for topical NSAID (rescue med) will be assessed at all post-op visits. If at any time the patient shows signs of cystoid macular edema, inflammation or pain, NSAIDs will be administered. The number of patients needing NSAID post-operatively will help determine if NSAIDS are needed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Anterior Chamber Cells From Baseline Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Omidria', 'description': 'Phenylephrine/Ketorolac (1%/0.3%) will be administered to all participants enrolled into the study.\n\nOmidria: Phenylephrine and Ketorolac infusion of 1%/0.3% during cataract surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '.08', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 6', 'description': 'Anterior chamber cells will be assessed through a dilated eye exam to determine if NSAIDS are needed post-operatively in addition to Omidria during surgery.\n\nRange and meaning (if score/scale): 0-2 0 = no cell\n\n1. = 10-20 cells\n2. = greater than 20 cells', 'unitOfMeasure': 'Cell Score - Score on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Omidria', 'description': 'Phenylephrine/Ketorolac (1%/0.3%) will be administered to all participants enrolled into the study.\n\nOmidria: Phenylephrine and Ketorolac infusion of 1%/0.3% during cataract surgery.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Omidria', 'description': 'Phenylephrine/Ketorolac (1%/0.3%) will be administered to all participants enrolled into the study.\n\nOmidria: Phenylephrine and Ketorolac infusion of 1%/0.3% during cataract surgery.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.7', 'spread': '7.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '64', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-12', 'size': 257896, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-10-12T11:03', 'hasProtocol': True}, {'date': '2020-12-14', 'size': 202723, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-09-24T09:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-29', 'studyFirstSubmitDate': '2019-02-13', 'resultsFirstSubmitDate': '2023-10-12', 'studyFirstSubmitQcDate': '2019-03-04', 'lastUpdatePostDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-29', 'studyFirstPostDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best Corrected Visual Acuity (BCVA) (Pre-op)', 'timeFrame': 'Baseline', 'description': 'Best vision will be tested with lens correction using Snellen Charts.'}, {'measure': 'Best Corrected Visual Acuity (BCVA) (Week 2)', 'timeFrame': '2 weeks', 'description': 'Best vision will be tested with lens correction using Snellen Charts to determine if improvements have been made post-operatively.'}, {'measure': 'Best Corrected Visual Acuity (BCVA) (Week 6)', 'timeFrame': '6 weeks', 'description': 'Best distance vision will be measured clinically to determine if improvements have been made post-operatively.'}, {'measure': 'Number of Participants That Develop Presence of Cystoid Macular Edema (CME)', 'timeFrame': '2 weeks', 'description': 'The number of participants that develop CME will be recorded to evaluate if Omidria is sufficient in controlling CME. The presence of CME will be determined clinically.'}, {'measure': 'Change From Baseline in Macular Thickness Measurement - Number in Microns', 'timeFrame': 'Baseline and week 6', 'description': 'The thickness of the macula will be measured pre and post operatively using ocular imaging to determine if Omidria is sufficient in controlling thickening post-operatively - measured in number of Microns'}, {'measure': 'Number of Participants Needing NSAID Post-operatively', 'timeFrame': 'Post-op weeks 1 through 6', 'description': 'Need for topical NSAID (rescue med) will be assessed at all post-op visits. If at any time the patient shows signs of cystoid macular edema, inflammation or pain, NSAIDs will be administered. The number of patients needing NSAID post-operatively will help determine if NSAIDS are needed.'}, {'measure': 'Change in Anterior Chamber Cells From Baseline Measurement', 'timeFrame': 'Week 6', 'description': 'Anterior chamber cells will be assessed through a dilated eye exam to determine if NSAIDS are needed post-operatively in addition to Omidria during surgery.\n\nRange and meaning (if score/scale): 0-2 0 = no cell\n\n1. = 10-20 cells\n2. = greater than 20 cells'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cataract']}, 'referencesModule': {'references': [{'pmid': '28366368', 'type': 'BACKGROUND', 'citation': 'Yang J, Cai L, Sun Z, Ye H, Fan Q, Zhang K, Lu W, Lu Y. Risk factors for and diagnosis of pseudophakic cystoid macular edema after cataract surgery in diabetic patients. J Cataract Refract Surg. 2017 Feb;43(2):207-214. doi: 10.1016/j.jcrs.2016.11.047.'}, {'pmid': '26232601', 'type': 'BACKGROUND', 'citation': 'Wielders LH, Lambermont VA, Schouten JS, van den Biggelaar FJ, Worthy G, Simons RW, Winkens B, Nuijts RM. Prevention of Cystoid Macular Edema After Cataract Surgery in Nondiabetic and Diabetic Patients: A Systematic Review and Meta-Analysis. Am J Ophthalmol. 2015 Nov;160(5):968-981.e33. doi: 10.1016/j.ajo.2015.07.032. Epub 2015 Jul 29.'}, {'pmid': '23321360', 'type': 'BACKGROUND', 'citation': 'Novack GD. Quality of generic ophthalmic drugs. Ocul Surf. 2013 Jan;11(1):54-6. doi: 10.1016/j.jtos.2012.10.002. Epub 2012 Oct 17. No abstract available.'}, {'pmid': '24935281', 'type': 'BACKGROUND', 'citation': 'Kessel L, Tendal B, Jorgensen KJ, Erngaard D, Flesner P, Andresen JL, Hjortdal J. Post-cataract prevention of inflammation and macular edema by steroid and nonsteroidal anti-inflammatory eye drops: a systematic review. Ophthalmology. 2014 Oct;121(10):1915-24. doi: 10.1016/j.ophtha.2014.04.035. Epub 2014 Jun 14.'}, {'pmid': '17720069', 'type': 'BACKGROUND', 'citation': 'Henderson BA, Kim JY, Ament CS, Ferrufino-Ponce ZK, Grabowska A, Cremers SL. Clinical pseudophakic cystoid macular edema. Risk factors for development and duration after treatment. J Cataract Refract Surg. 2007 Sep;33(9):1550-8. doi: 10.1016/j.jcrs.2007.05.013.'}, {'pmid': '18721711', 'type': 'BACKGROUND', 'citation': 'Bucci FA Jr, Waterbury LD. Comparison of ketorolac 0.4% and bromfenac 0.09% at trough dosing: aqueous drug absorption and prostaglandin E2 levels. J Cataract Refract Surg. 2008 Sep;34(9):1509-12. doi: 10.1016/j.jcrs.2008.05.023.'}, {'pmid': '29227185', 'type': 'BACKGROUND', 'citation': 'Waterbury LD. Alternative Drug Delivery for Patients Undergoing Cataract Surgery as Demonstrated in a Canine Model. J Ocul Pharmacol Ther. 2018 Jan/Feb;34(1-2):154-160. doi: 10.1089/jop.2017.0048. Epub 2017 Dec 11.'}, {'pmid': '20159228', 'type': 'BACKGROUND', 'citation': 'Kim SJ, Flach AJ, Jampol LM. Nonsteroidal anti-inflammatory drugs in ophthalmology. Surv Ophthalmol. 2010 Mar-Apr;55(2):108-33. doi: 10.1016/j.survophthal.2009.07.005.'}, {'pmid': '29778106', 'type': 'BACKGROUND', 'citation': 'Wielders LHP, Schouten JSAG, Winkens B, van den Biggelaar FJHM, Veldhuizen CA, Findl O, Murta JCN, Goslings WRO, Tassignon MJ, Joosse MV, Henry YP, Rulo AHF, Guell JL, Amon M, Kohnen T, Nuijts RMMA; ESCRS PREMED Study Group. European multicenter trial of the prevention of cystoid macular edema after cataract surgery in nondiabetics: ESCRS PREMED study report 1. J Cataract Refract Surg. 2018 Apr;44(4):429-439. doi: 10.1016/j.jcrs.2018.01.029.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effect of Intraocular Phenylephrine/Ketorolac Infusion on Retinal Thickness and Macular Edema in Cataract Surgery. Participants will receive infusions of Phenylephrine/Ketorolac during surgery instead of receiving topical NSAID drops pre and post operatively.', 'detailedDescription': 'Topical NSAIDs have been known to reduce post-operative macular edema, inflammation and pain in patients undergoing cataract surgery. Routine cataract surgery without the protection of topical NSAIDs results in an increase of the number of patients with macular edema and macular thickening.\n\nOmidria (phenylephrine and ketorolac injection 1%/0.3%) infusion is used in patients during cataract surgery to decrease post-operative pain and inflammation. It is also indicated to maintain pupil dilation during cataract surgery.\n\nThis study will evaluate whether treating patients with Omidria during cataract surgery will control post-operative pain and inflammation as well as reduce or eliminate macular edema without the use of adjunctive topical NSAIDs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults age 55-90 years with visual significant cataracts in one or both eyes.\n* Healthy individuals able to tolerate outpatient cataract surgery under local anesthesia via either phacoemulsification and/or femtosecond assisted cataract surgery. Well-controlled diabetes, hypertension will be included.\n* Females of childbearing potential must agree to use a reliable method of birth control while participating in this study. Reliable methods of birth control are: abstinence, oral contraceptives, intrauterine device (IUD), DepoProvera, tubal ligation or vasectomy of the partner (with confirmed negative sperm counts) in monogamous relationship (same partner). An acceptable, although less reliable, method involves the careful use of condoms and spermicidal foam or gel and/or cervical cap or sponge. A pregnancy test is required at least 10 days from the last normal menstrual period, if the patient is a sexually active female of childbearing potential.\n\nExclusion Criteria:\n\n* Allergy to Phenylephrine or NSAIDs.\n* Inability to sit steady and upright for the Optical Coherence Tomography (OCT).\n* Complications during surgery, including posterior capsular rupture, vitreous loss, zonular dialysis, or iris trauma.\n* Macular thickness above 300 microns at baseline\n* Currently taking a prostaglandin analogue\n* Presence of an epiretinal membrane on the preoperative OCT.\n* Retained lens fragment post-operatively.\n* Inability to return for follow appointments\n* Female patients who are pregnant, lactating or planning to become pregnant during the course of treatment.'}, 'identificationModule': {'nctId': 'NCT03864133', 'briefTitle': 'No Drop Post-Op Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'The Effects of Intraocular Phenylephrine/Ketorolac Infusion on Retinal Thickness and Macular Edema in Cataract Surgery', 'orgStudyIdInfo': {'id': 'IRB00050415'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Omidria', 'description': 'Phenylephrine/Ketorolac (1%/0.3%) will be administered to all participants enrolled into the study.', 'interventionNames': ['Drug: Omidria']}], 'interventions': [{'name': 'Omidria', 'type': 'DRUG', 'description': 'Phenylephrine and Ketorolac infusion of 1%/0.3% during cataract surgery.', 'armGroupLabels': ['Omidria']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Keith Walter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Omeros Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}