An interventional study of air and Gas SF6 (Sulfur Hexafluoride) and others in Retinal Detachment Rhegmatogenous, sponsored by Liverpool University Hospitals NHS Foundation Trust. Not yet recruiting. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-12-24.
Sponsored by Liverpool University Hospitals NHS Foundation Trust · Not applicable, Interventional, and Treatment
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.
STUDY OBJECTIVES To assess whether air tamponade is non inferior to gas tamponade for the repair of RRD with superior breaks treated with vitrectomy and to assess how cost-effective air tamponade is compared to gas tamponade BACKGROUND Rhegmatogenous retinal detachment (RRD) is the most common form of RD developing when there is a retinal 'break' that allows the ingress of fluid from the vitreous cavity into the subretinal space. There are three main current options for the management of RRD, namely pneumoretinopexy, scleral buckling and vitrectomy (PPV). Vitrectomy is currently performed for the majority of RRDs in the UK. Tamponade in PPV is usually performed by complete filling of the vitreous cavity with fluorinated gases diluted in air at iso-volumetric concentrations which do not expand (e.g., 20% SF6 or 14% C3F8).
RATIONALE FOR CURRENT STUDY The use of air instead of fluorinated gases in primary RRD treated with vitrectomy has been the subject of much debate recently. Air being non expansile and short lived it offers the prospect of quicker rehabilitation and less risk and avoids the use of environmentally damaging fluorinated gases. The question of whether air offers equivalence to gas for uncomplicated RRD with mainly superior breaks has not been adequately answered, as reviewed in a recent systematic review and meta-analysis where the certainty of evidence was judged very low. This type of detachment is the commonest at approximately 60% of the cases in the BEAVRS database and representing approximately 4,800 RRD in the UK per annum. There has been significant interest in air recently with the announcement of the European chemical agencies proposed ban on fluorinated gases.
There are several potential benefits of using air over gas to repair detached retinas.
Participants will be randomised 1:1 between air tamponade and gas tamponade. Randomisation will be performed using a secure web-based randomisation system at the time of surgery.
207 studies on the registry are indexed under Retinal Detachment; 27 are open to participants now.
This study's planned enrollment of 150 is above the median of 50 across 136 interventional studies indexed under Retinal Detachment.
Browse Retinal Detachment studies →Liverpool University Hospitals NHS Foundation Trust is the lead sponsor of 60 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
use of sterile air in place of fluorinated gases as a tamponade agent for rhegmatogenous retinal detachment vitrectomy surgery
Procedure: air
use of fluorinated gas (SF6, C2F6 or C3F8) as a tamponade agent for rhegmatogenous retinal detachment treated with vitrectomy
Procedure: Gas SF6 (Sulfur Hexafluoride) and others
use of sterile air as a tamponade
use 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'
Time frame: 6 months
Post op visual acuity
Postoperative visual acuity at 10 days, 6 and 24 weeks measured either in Snellen or logMAR
Time frame: 10 days, 6 weeks and 24 weeks
Intraocular pressure
Day 1, Day 10-, 6- and 24-weeks intraocular pressure measured in mmHg
Time frame: Day 1, 10 and 6 and 24 weeks
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.
Time frame: 10 days, 6 and 24 weeks
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
Time frame: 10 days, 6 and 24 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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Liverpool University Hospitals NHS Foundation Trust