Cataract Clinical Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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