Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-03-07 @ 9:26 PM
Study NCT ID:
NCT01843920
Status:
COMPLETED
Last Update Posted:
2018-05-30
First Post:
2013-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Glaucoma Drops on of the Duration of a Pure Intraocular Gas Bubble
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C479140', 'term': 'dorzolamide-timolol combination'}, {'id': 'C062765', 'term': 'dorzolamide'}, {'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011112', 'term': 'Polymyxin B'}, {'id': 'D014295', 'term': 'Trimethoprim'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'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'}, {'id': 'D011113', 'term': 'Polymyxins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D055666', 'term': 'Lipopeptides'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D023181', 'term': 'Antimicrobial Cationic Peptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000089882', 'term': 'Antimicrobial Peptides'}, {'id': 'D052899', 'term': 'Pore Forming Cytotoxic Proteins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'research@midatlanticretina.com', 'phone': '215-928-3092', 'title': 'Jason Hsu, MD', 'organization': 'Mid Atlantic Retina'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Post Surgery Without Glaucoma Drops', 'description': 'This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.\n\nstandard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Post Surgery With Glaucoma Drops', 'description': 'This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.\n\nTimolol-dorzolamide (Glaucoma drops): Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.\n\nstandard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim', 'otherNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Complete Resolution of Intraocular Gas Bubble', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Post Surgery Without Glaucoma Drops', 'description': 'This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.\n\nstandard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim'}, {'id': 'OG001', 'title': 'Post Surgery With Glaucoma Drops', 'description': 'This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.\n\nTimolol-dorzolamide (Glaucoma drops): Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.\n\nstandard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim'}], 'classes': [{'categories': [{'measurements': [{'value': '40.4', 'groupId': 'OG000', 'lowerLimit': '27', 'upperLimit': '51'}, {'value': '37.8', 'groupId': 'OG001', 'lowerLimit': '29', 'upperLimit': '50'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Following surgery, until gas bubble is gone. Up to 2 months.', 'description': 'This will be reported by the patient when they see/feel the gas bubble disappear.', 'unitOfMeasure': 'Duration in days, gas bubble', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Return of Intraocular Pressure to Normal Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Post Surgery Without Glaucoma Drops', 'description': 'This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.\n\nstandard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim'}, {'id': 'OG001', 'title': 'Post Surgery With Glaucoma Drops', 'description': 'This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.\n\nTimolol-dorzolamide (Glaucoma drops): Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.\n\nstandard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim'}], 'classes': [{'categories': [{'title': 'High IOP at Month 2', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Normal IOP at Month 2', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Low IOP at Month 2', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Data Not Available', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 2', 'description': 'Number of participants with a normal intraocular pressure of 10-21 mm Hg at the Month 2 visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Post Surgery Without Glaucoma Drops', 'description': 'This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.\n\nstandard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim'}, {'id': 'FG001', 'title': 'Post Surgery With Glaucoma Drops', 'description': 'This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.\n\nTimolol-dorzolamide (Glaucoma drops): Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.\n\nstandard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Post Surgery Without Glaucoma Drops', 'description': 'This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.\n\nstandard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim'}, {'id': 'BG001', 'title': 'Post Surgery With Glaucoma Drops', 'description': 'This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.\n\nTimolol-dorzolamide (Glaucoma drops): Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.\n\nstandard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-30', 'studyFirstSubmitDate': '2013-04-18', 'resultsFirstSubmitDate': '2014-05-27', 'studyFirstSubmitQcDate': '2013-04-26', 'lastUpdatePostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-12-13', 'studyFirstPostDateStruct': {'date': '2013-05-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Resolution of Intraocular Gas Bubble', 'timeFrame': 'Following surgery, until gas bubble is gone. Up to 2 months.', 'description': 'This will be reported by the patient when they see/feel the gas bubble disappear.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Return of Intraocular Pressure to Normal Levels', 'timeFrame': 'Month 2', 'description': 'Number of participants with a normal intraocular pressure of 10-21 mm Hg at the Month 2 visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['eye', 'pneumatic retinopexy', 'topical'], 'conditions': ['Scleral Buckling']}, 'descriptionModule': {'briefSummary': 'A controlled clinical study comparing the effect of topical aqueous suppressants on intraocular gas duration.', 'detailedDescription': 'A Prospective, Randomized Study Comparing the Effects of Topical Aqueous Suppressants on Intraocular Gas Duration following Scleral Buckling and Pneumatic Retinopexy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to provide written informed consent and comply with study assessments for the full duration of the study.\n* Have undergone eye surgery including scleral buckling or pneumatic retinopexy for treatment of retinal detachment other condition at the discretion of the investigator.\n\nExclusion Criteria:\n\n* Prior surgery to treat glaucoma.\n* Current use of glaucoma eye drops.\n* Absence of a lens in the eye or presence of a lens implant in front of the iris (colored part of your eye).\n* Allergy or contraindication to any of the glaucoma drops being used in this study (e.g., sulfa allergy, asthma, chronic obstructive pulmonary disease (bronchitis or emphysema), slow heart rate).'}, 'identificationModule': {'nctId': 'NCT01843920', 'briefTitle': 'The Effect of Glaucoma Drops on of the Duration of a Pure Intraocular Gas Bubble', 'organization': {'class': 'OTHER', 'fullName': 'Wills Eye'}, 'officialTitle': 'A Prospective, Randomized Study Comparing the Effects of Topical Aqueous Suppressants on Intraocular Gas Duration Following Scleral Buckling and Pneumatic Retinopexy.', 'orgStudyIdInfo': {'id': '11095 Gas Duration'}, 'secondaryIdInfos': [{'id': '11-095', 'type': 'OTHER', 'domain': 'Wills Eye IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Post surgery without glaucoma drops', 'description': 'This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.', 'interventionNames': ['Drug: standard post-operative topical drops']}, {'type': 'EXPERIMENTAL', 'label': 'Post surgery with glaucoma drops', 'description': 'This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.', 'interventionNames': ['Drug: Timolol-dorzolamide (Glaucoma drops)', 'Drug: standard post-operative topical drops']}], 'interventions': [{'name': 'Timolol-dorzolamide (Glaucoma drops)', 'type': 'DRUG', 'otherNames': ['timol', 'glaucoma drops', 'dorzolamide', 'timol-dorzolamide'], 'description': 'Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.', 'armGroupLabels': ['Post surgery with glaucoma drops']}, {'name': 'standard post-operative topical drops', 'type': 'DRUG', 'otherNames': ['glaucoma', 'drops', 'standard of care', 'oral', 'corticosteroid', 'prednisolone', 'Polymyxin B', 'trimethoprim'], 'description': 'Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim', 'armGroupLabels': ['Post surgery with glaucoma drops', 'Post surgery without glaucoma drops']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Mid Atlantic Retina- Wills Eye Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Jason Hsu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wills Eye Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jason Hsu, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Jason Hsu, MD', 'investigatorAffiliation': 'Wills Eye'}}}}