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The primary purpose of the study was to compare the macular hole closure and visual acuity gain following vitrectomy using SF6 gas tamponade with 7 days of face-down positioning versus C3F8 gas tamponade with 14 days of face-down positioning. The secondary purpose was to report, in each group, the cumulative incidence of cataract development 1 year following macular hole surgery and the proportion of complications (\*). ((\*) hypertony, hypotony, retinal tear, retinal detachment and endophthalmitis) This prospective randomized study examined a 3 year period. The first patient was included in January 2010 and the last in November 2011. The 12-month follow-up spread out from March 2011 to December 2012. The first group included 31 patients who had undergone macular hole surgery using SF6 gas and who were advised to stay in face-down position for 7 days postoperatively (SF6 group). These patients were compared to 28 patients who had undergone macular hole surgery with C3F8 gas and who were advised to maintain a face-down position for 14 days. Patients in both groups underwent vitrectomy, internal limiting membrane peeling, and fluid-gas exchange using either SF6 or C3F8. Preoperative data included the characterization of the hole with Optical Coherence Tomography (OCT), the best correct visual acuity (VA) recorded in number of letters using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart, classification of the cataract according to the LOCS III and the intraocular pressure IOP. Postoperative data included OCT confirmation of the closure at 6 weeks and 1 year, 1 year's best corrected VA recorded in number of letters (EDTRS chart) and determination of cataract development and extraction as needed.
Age
51 - 83 years
Sex
ALL
Healthy Volunteers
Yes
Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec
Québec, Quebec, Canada
Start Date
January 1, 2010
Primary Completion Date
December 1, 2012
Completion Date
May 1, 2013
Last Updated
July 26, 2016
59
ACTUAL participants
Macular hole surgery using a 25 G pars plana vitrectomy, ILM peeling, fluid-air exchange followed by air-gas exchange with SF6 or C3F8.
PROCEDURE
Lead Sponsor
CHU de Quebec-Universite Laval
NCT06979752
NCT07362043
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06060041