Retinal Detachment RhegmatogenousGREENNCT07034469
Air Tamponade Versus Fluorinated Gas Tamponade for Rhegmatogenous Retinal Detachment
A study testing air and Gas SF6 (Sulfur Hexafluoride) and others in people with Retinal Detachment Rhegmatogenous, run by Liverpool University Hospitals NHS Foundation Trust.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Retinal Detachment Rhegmatogenous
- What is being tested?
- air and Gas SF6 (Sulfur Hexafluoride) and others
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2026to 20 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Absence of PVD
- Age 40 years or younger
- PVR grade C or above
- Aphakia or anterior chamber lens
- Retinal breaks greater than 1 clock hour in size
- Retinal breaks that exist below 3 and 9 o'clock on both the nasal and temporal sides.
Show all 14Show fewer
- Retinal breaks at or posterior to the vessel arcades
- Current or previous -6D myopia or greater (or axial length >26millimetres (mm))
- Chronic RRD judged by the presence of subretinal bands and other signs of -chronicity or by history of visual loss for >28 days.
- Significant inflammation, choroidal detachments, hypotony (<6 millimetres of mercury (mmHg) preop)
- Previous open-globe injury, or endophthalmitis
- Current or previous posterior uveitis or choroiditis
- Any intraocular surgical procedure within 4 weeks other than laser/cryotherapy
- Any other condition that, in the opinion of the investigator, would prevent the participant from granting informed consent or complying with the protocol.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Darina Koneva contact
About this study
Official title: Gas Tamponade Versus Air During Vitrectomy for Rhegmatogenous rEtinal dEtachmeNt; a Randomised Controlled Trial
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.
Read the detailed description
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.
- Speedier visual recovery, which may mean earlier return to work or normal activities.
- Avoiding expansile fluorinated gas-related complications such as raised eye pressure, reducing the number of post-operative visits and medications needed after surgery.
- Fewer restrictions after surgery (able to fly and drive sooner and shorter restrictions on anaesthetic agents)
- Decreased environmental impact by reducing greenhouse gas use. If air was proven to be non-inferior to gas, then patients with RRD treated by vitrectomy would likely prefer it STUDY DESIGN RCT of people presenting with uncomplicated RRD treated with vitrectomy comparing air to gas tamponade.
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.
- Conditions
- Retinal Detachment Rhegmatogenous
- Being tested
- air, Gas SF6 (Sulfur Hexafluoride) and others
- Keywords
- retinal detachment, gas tamponade, air
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
airProcedure or surgery
use of sterile air as a tamponade
Gas SF6 (Sulfur Hexafluoride) and othersProcedure or surgery
use of fluorinated gases such as SF6, C2F6 or C3F8 as a tamponade agent
| Study group | Role | What they receive |
|---|---|---|
| Sterile air tamponade | Experimental | use of sterile air in place of fluorinated gases as a tamponade agent for rhegmatogenous retinal detachment vitrectomy surgery Receives: Procedure: air |
| Fluorinated gas tamponade | Active comparator | use of fluorinated gas (SF6, C2F6 or C3F8) as a tamponade agent for rhegmatogenous retinal detachment treated with vitrectomy Receives: Procedure: Gas SF6 (Sulfur Hexafluoride) and others |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'
Measured: 6 months
Secondary outcomes (4)
Post op visual acuity
Postoperative visual acuity at 10 days, 6 and 24 weeks measured either in Snellen or logMAR
Measured: 10 days, 6 weeks and 24 weeks
Intraocular pressure
Day 1, Day 10-, 6- and 24-weeks intraocular pressure measured in mmHg
Measured: 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.
Measured: 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
Measured: 10 days, 6 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start20 Mar 2026 (estimated)
- Primary completion20 Mar 2029 (estimated)
- Study completion20 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Detachment RhegmatogenousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- one arm will have standard of care gas tamponade, the study arm will have air tamponade
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Rumana N Hussain, MBBS, FRCOph, Principal investigator, Liverpool University Hospitals NHS Foundation Trust UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034469
- Sponsor's protocol ID
- LHS0250
- Acronym
- GREEN
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2024
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gas Tamponade Versus Air During Vitrectomy for Rhegmatogenous rEtinal dEtachmeNt; a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07034469
- Acronym / sponsor ID
- GREEN / LHS0250
- Conditions
- Retinal Detachment Rhegmatogenous
- Keywords
- retinal detachment, gas tamponade, air
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Liverpool University Hospitals NHS Foundation TrustOther government
- Study start
- 20 Mar 2026 (estimated)
- Primary completion
- 20 Mar 2029 (estimated)
- Study completion
- 20 Mar 2029 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
- Speedier visual recovery, which may mean earlier return to work or normal activities.
- Avoiding expansile fluorinated gas-related complications such as raised eye pressure, reducing the number of post-operative visits and medications needed after surgery.
- Fewer restrictions after surgery (able to fly and drive sooner and shorter restrictions on anaesthetic agents)
- Decreased environmental impact by reducing greenhouse gas use. If air was proven to be non-inferior to gas, then patients with RRD treated by vitrectomy would likely prefer it STUDY DESIGN RCT of people presenting with uncomplicated RRD treated with vitrectomy comparing air to gas tamponade.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- one arm will have standard of care gas tamponade, the study arm will have air tamponade
| Arm | Type | Receives |
|---|---|---|
| Sterile air tamponade | Experimental | Procedure: airuse of sterile air in place of fluorinated gases as a tamponade agent for rhegmatogenous retinal detachment vitrectomy surgery |
| Fluorinated gas tamponade | Active comparator | Procedure: Gas SF6 (Sulfur Hexafluoride) and othersuse of fluorinated gas (SF6, C2F6 or C3F8) as a tamponade agent for rhegmatogenous retinal detachment treated with vitrectomy |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- Absence of PVD
- Age 40 years or younger
- PVR grade C or above
- Aphakia or anterior chamber lens
- Retinal breaks greater than 1 clock hour in size
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| airuse of sterile air as a tamponade | Procedure or surgery | Sterile air tamponade |
| Gas SF6 (Sulfur Hexafluoride) and othersuse of fluorinated gases such as SF6, C2F6 or C3F8 as a tamponade agent | Procedure or surgery | Fluorinated gas tamponade |
Primary outcome
Primary anatomical success
Time frame: 6 months
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'
4 secondary outcomes
Post op visual acuity
Time frame: 10 days, 6 weeks and 24 weeks
Intraocular pressure
Time frame: Day 1, 10 and 6 and 24 weeks
Quality of Life measures
Time frame: 10 days, 6 and 24 weeks
Patient Satisfaction
Time frame: 10 days, 6 and 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Darina Koneva contact
Rumana N Hussain, MBBS, FRCOph principal investigator
Liverpool University Hospitals NHS Foundation Trust UK
Questions about this trial
What is this clinical trial studying?
A study testing air and Gas SF6 (Sulfur Hexafluoride) and others in people with Retinal Detachment Rhegmatogenous, run by Liverpool University Hospitals NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rumana N Hussain, MBBS, FRCOph (01517063986, rumana.hussain@liverpoolft.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary anatomical success (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.