TITLE: RCT of air tamponade versus fluorinated gas tamponade for rhegmatogenous retinal detachment DESIGN: Non-inferiority RCT of 150 patients from 10 UK centres AIMS: To assess whether air tamponade is non inferior to gas tamponade for the repair of RRD treated with vitrectomy.
PRIMARY OUTCOME MEASURE: Primary anatomical success with single operation at 24 weeks.
Primary uncomplicated RRD undergoing vitrectomy.
Phakic and pseudophakic eyes
Retinal breaks superiorly between 3 and 9 o'clock, and that are separated by less than 4 clock hours.
Absence of PVD
Age 40 years or younger
PVR grade C or above
Aphakia or anterior chamber lens
Parallel
air
Procedure/Surgeryuse of sterile air as a tamponade
Gas SF6 (Sulfur Hexafluoride) and others
Procedure/Surgeryuse of fluorinated gases such as SF6, C2F6 or C3F8 as a tamponade agent
Primary anatomical success
Primary anatomical success at 24 weeks assessed by clinical examination by a retinal surgeon. The Outcome is binary with either 'successful retinal reattachement' or 'failed surgery'
Post op visual acuity
Postoperative visual acuity at 10 days, 6 and 24 weeks measured either in Snellen or logMAR
Intraocular pressure
Day 1, Day 10-, 6- and 24-weeks intraocular pressure measured in mmHg
Quality of Life measures
Generic and vision related quality of life using the Euro quality of Life and Visual function questionnaire at 10 days, 6 and 24 weeks postoperatively. These questionnaires have sections relating to ocular health eg vision, ocular pain etc and impact on daily activities. They create a composite score combining each section, which ranges from 0-100 with higher scores reflecting better vision related quality of life.
Patient Satisfaction
Patient satisfaction with treatment using the Macular Disease Treatment Satisfaction Questionnaire at 10 days, 6 and 24 weeks. This questionnaire is a self administered questionnaire with a 7 point (0-6) scoring over 14 domains with a total score of 0-72, with higher scores reflecting greater satisfaction
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