Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-02-24 @ 8:27 AM
Study NCT ID:
NCT02477605
Status:
COMPLETED
Last Update Posted:
2018-07-02
First Post:
2015-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Comparison of 27+® and 23-gauge ULTRAVIT® 7500 Cpm Vitrectomy Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Brand Lead, Global Medical Affairs', 'organization': 'Alcon, A Novartis Division'}, 'certainAgreement': {'otherDetails': 'Sponsor reserves the right of prior review of any publication or presentation of information related to the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months).", 'description': 'An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.', 'eventGroups': [{'id': 'EG000', 'title': '27-Gauge Treated Eye', 'description': 'Ocular events, treated (study) eye', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 18, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': '27-Gauge Fellow Eye', 'description': 'Ocular events, untreated (fellow) eye', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 0, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '27-Gauge Systemic', 'description': 'Non-ocular adverse events', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 0, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '23-Gauge Treated Eye', 'description': 'Ocular events, treated (study) eye', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 14, 'seriousNumAtRisk': 69, 'deathsNumAffected': 0, 'seriousNumAffected': 16}, {'id': 'EG004', 'title': '23-Gauge Fellow Eye', 'description': 'Ocular events, untreated (fellow) eye', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 0, 'seriousNumAtRisk': 69, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': '23-Gauge Systemic', 'description': 'Non-ocular adverse events', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 0, 'seriousNumAtRisk': 69, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Conjunctival oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Punctate keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'seriousEvents': [{'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypotony of eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Macular fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Macular hole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Retinal tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Retinopathy proliferative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Intraocular pressure decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Craniotomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Eye laser surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Eye operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Retinal laser coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Retinal operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Vitrectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change in Intraocular Pressure (IOP) on Operative Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '27-Gauge', 'description': 'CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery'}, {'id': 'OG001', 'title': '23-Gauge', 'description': 'CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.40', 'spread': '6.603', 'groupId': 'OG000'}, {'value': '-3.05', 'spread': '7.639', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 preoperative, Day 0 postoperative', 'description': 'IOP (fluid pressure inside the eye) was assessed using the study specified tono-pen and measured in millimeters of mercury (mmHg). Change was defined as the difference between immediate postoperative IOP and immediate preoperative IOP. A greater change in IOP may indicate a less stable posterior chamber and/or a more invasive surgery.', 'unitOfMeasure': 'mmHG', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with data.'}, {'type': 'SECONDARY', 'title': 'Mean Conjunctival Edema Score at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '27-Gauge', 'description': 'CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery'}, {'id': 'OG001', 'title': '23-Gauge', 'description': 'CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'spread': '0.124', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.246', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1 post operative', 'description': 'Conjunctival edema (swelling) was assessed during examination by the investigator and graded on a scale of 0-3, where 0=Absent and 3=Severe. Each sclerotomy wound was graded as infusion, vitrectomy probe, and illuminator and the average of the three was the overall Conjunctival Edema Score at the visit. Only one eye (study eye) contributed to the analysis.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Set. Number Analyzed is the number of subjects with data.'}, {'type': 'SECONDARY', 'title': 'Mean Post-operative Pain Rating at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '27-Gauge', 'description': 'CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery'}, {'id': 'OG001', 'title': '23-Gauge', 'description': 'CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '1.75', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 post operative', 'description': 'The subject was asked to rate post-operative pain in the study eye using a score of 0-10, where 0=no pain and 10=the worst pain imaginable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '27-Gauge', 'description': 'CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery'}, {'id': 'FG001', 'title': '23-Gauge', 'description': 'CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'Randomized and Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Discontinued prior to treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Administered gas during surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects were recruited from 6 study centers located in the US.', 'preAssignmentDetails': 'Of the 137 enrolled, 1 subject was exited as a screen failure prior to randomization. This reporting group includes all randomized subjects (136).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '27-Gauge', 'description': 'CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery'}, {'id': 'BG001', 'title': '23-Gauge', 'description': 'CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.8', 'spread': '11.55', 'groupId': 'BG000'}, {'value': '67.0', 'spread': '11.65', 'groupId': 'BG001'}, {'value': '66.4', 'spread': '11.57', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This analysis population includes all randomized subjects (Intent-to-Treat Analysis Set).'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2016-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-31', 'studyFirstSubmitDate': '2015-06-18', 'resultsFirstSubmitDate': '2017-05-30', 'studyFirstSubmitQcDate': '2015-06-18', 'lastUpdatePostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-28', 'studyFirstPostDateStruct': {'date': '2015-06-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in Intraocular Pressure (IOP) on Operative Day', 'timeFrame': 'Day 0 preoperative, Day 0 postoperative', 'description': 'IOP (fluid pressure inside the eye) was assessed using the study specified tono-pen and measured in millimeters of mercury (mmHg). Change was defined as the difference between immediate postoperative IOP and immediate preoperative IOP. A greater change in IOP may indicate a less stable posterior chamber and/or a more invasive surgery.'}], 'secondaryOutcomes': [{'measure': 'Mean Conjunctival Edema Score at Week 1', 'timeFrame': 'Week 1 post operative', 'description': 'Conjunctival edema (swelling) was assessed during examination by the investigator and graded on a scale of 0-3, where 0=Absent and 3=Severe. Each sclerotomy wound was graded as infusion, vitrectomy probe, and illuminator and the average of the three was the overall Conjunctival Edema Score at the visit. Only one eye (study eye) contributed to the analysis.'}, {'measure': 'Mean Post-operative Pain Rating at Day 1', 'timeFrame': 'Day 1 post operative', 'description': 'The subject was asked to rate post-operative pain in the study eye using a score of 0-10, where 0=no pain and 10=the worst pain imaginable.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Vitreoretinal Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the treatment day change between immediate postoperative and immediate preoperative intraocular pressure (IOP) between 27-gauge and 23-gauge vitrectomy instruments.', 'detailedDescription': 'Required follow-up for this study is 3 months post treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing and able to provide informed consent and attend all required study visits;\n* Requires vitrectomy in at least one eye;\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Previous vitrectomy or glaucoma surgery;\n* Planned treatment requires scleral buckling, combined procedures (eg, cataract surgery), silicone oil, and expansive gas other than sterile air;\n* Treated with topical IOP lowering medication(s) at any time from baseline assessment to time of surgery;\n* Pregnant or planning to become pregnant during the course of the trial;\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02477605', 'briefTitle': 'Clinical Comparison of 27+® and 23-gauge ULTRAVIT® 7500 Cpm Vitrectomy Outcomes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Clinical Comparison of 27+® and 23-gauge ULTRAVIT® 7500 Cpm Vitrectomy Outcomes', 'orgStudyIdInfo': {'id': 'VRH172-P001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '27-gauge pak', 'description': 'CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery', 'interventionNames': ['Device: CONSTELLATION® 27-gauge Combined Surgical Pak', 'Procedure: Vitrectomy surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': '23-gauge pak', 'description': 'CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery', 'interventionNames': ['Device: CONSTELLATION® 23-gauge Combined Surgical Pak', 'Procedure: Vitrectomy surgery']}], 'interventions': [{'name': 'CONSTELLATION® 27-gauge Combined Surgical Pak', 'type': 'DEVICE', 'description': 'Sterile single-use supplies necessary to perform 1 vitrectomy surgery: 1 ULTRAVIT® 27-gauge 7500 cuts per minute (cpm) vitrectomy probe and a 27-gauge EDGEPLUS® Valved Entry System comprised of 3 trocar/cannulas and related accessories.', 'armGroupLabels': ['27-gauge pak']}, {'name': 'CONSTELLATION® 23-gauge Combined Surgical Pak', 'type': 'DEVICE', 'description': 'Sterile single-use supplies necessary to perform 1 vitrectomy surgery: 1 ULTRAVIT® 23-gauge 7500 cuts per minute (cpm) vitrectomy probe and a 23-gauge EDGEPLUS® trocar/cannula set comprising of 3 trocars/cannulas and related accessories.', 'armGroupLabels': ['23-gauge pak']}, {'name': 'Vitrectomy surgery', 'type': 'PROCEDURE', 'description': 'Microincisional pars plana vitrectomy (PPV) surgery for the treatment of various vitreoretinal diseases ranging from simple to advanced cases', 'armGroupLabels': ['23-gauge pak', '27-gauge pak']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76134', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Contact Alcon Call Center for Trial Locations', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}], 'overallOfficials': [{'name': 'Clinical Manager, Surgical, GCRA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon, A Novartis Division'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}