Comparing 4 approaches for retinal detachment
Official title: REtinal Detachment Outcomes Study
Rhegmatogenous rEtinal Detachment With or withOut Scleral Buckle (REDOS) Trial: a Factorial, Randomized Controlled Trial
- 4 groups
- One site, in Québec
- Recruiting
Interventions (4)
- Medical procedure
Pars plana vitrectomy
Pars plana vitrectomy will be performed in a standard fashion starting with central vitrectomy, then by localizing retinal breaks, and marking them with endodiathermy. Perfluorocarbon will be used to displace subretinal fluid which will be aspirated at its exit from the retinal break as much as possible and maximal vitreous base shaving will be performed in all cases. This will be followed by an air-fluid exchange. Use of cryotherapy to solidify the retina intraoperatively and use of internal limiting membrane peeling of the posterior pole will be at the discretion of the surgeon. In all cases, laser photocoagulation around retinal breaks, holes, areas of lattice degeneration, and posterior to sclerotomy sites will be done and then a 360° laser retinopexy will be performed at the surgeon's discretion and consisted of three rows of medium-white burns anterior to the level of the vortex vein, towards and beyond the equator.
- Medical procedure
Pars plana vitrectomy with scleral buckle
In cases with SB, after 360° peritomy and dissection in 4 quadrants, a 41-circling band with 3082 sleeves (Labtician Ophthalmics, Oakville, ON Canada) will be used in all cases and fixed to the sclera at approximatively 11.5 mm from the limbus (or 5.5 from the insertion of rectus muscles) using partial thickness scleral tunnel or mattress sutures with 5.0 prolene or nylon performed in 4 quadrants depending on the surgeon preferences. Pars plana vitrectomy will then be performed as in the PPV only group.
- Other intervention
Sulfur hexafluoride gas tamponade
At the end of the surgery, the eye is filled with sulfur hexafluoride gas tamponade.
- Other intervention
Perfluoropropane gas
At the end of the surgery, the eye is filled with perfluoropropane gas tamponade.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Hôpital du Saint-Sacrement, CHU de Québec - Université Laval
Québec, Quebec
Eligibility Criteria
See who this study is looking for40 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age ≥18 years
- +Diagnosis of rhegmatogenous retinal detachment
- +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →, retinal detachment with:
- +Proliferative vitreoretinopathy (PVR) grade ≥C2
- +Chronic RRD with duration \>3 months
- +Proliferative diabetic retinopathy with tractional retinal detachment (RD)
- +Macular holes
- +Epiretinal membrane grade 3 or 4
- +Traumatic RD
- +Giant retinal tears
- +Retinal dialysis
- +Foveoschisis
- +Wet age-related macular degeneration
- +Endophthalmitis
- +Acute retinal necrosis
- +Coats disease
- +Retinopathy of prematurity
- +Retinoschisis
- +Retinal colobomas
- +Superior RD extent less than 3 clock hours (favoring PPV only)
- +Prior glaucoma surgery or strabismus surgery (favoring PPV only)
Exclusion
- −, retinal detachment with:
- −Proliferative vitreoretinopathy (PVR) grade ≥C2
- −Chronic RRD with duration \>3 months
- −Proliferative diabetic retinopathy with tractional retinal detachment (RD)
- −Macular holes
- −Epiretinal membrane grade 3 or 4
- −Traumatic RD
- −Giant retinal tears
- −Retinal dialysis
- −Foveoschisis
- −Wet age-related macular degeneration
- −Endophthalmitis
- −Acute retinal necrosis
- −Coats disease
- −Retinopathy of prematurity
- −Retinoschisis
- −Retinal colobomas
- −Superior RD extent less than 3 clock hours (favoring PPV only)
- −Prior glaucoma surgery or strabismus surgery (favoring PPV only)
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 4 groups in this study.
Group A, the comparison group, receives Pars plana vitrectomy and Sulfur hexafluoride gas tamponade.
Registry label: A: Pars plana vitrectomy + sulfur hexafluoride gas tamponade
Group B receives Pars plana vitrectomy with scleral buckle and Sulfur hexafluoride gas tamponade.
Registry label: B: Pars plana vitrectomy with scleral buckle + sulfur hexafluoride gas tamponade
Group C receives Pars plana vitrectomy and Perfluoropropane gas.
Registry label: C: Pars plana vitrectomy + perfluoropropane gas tamponade
Group D receives Pars plana vitrectomy with scleral buckle and Perfluoropropane gas.
Registry label: D: Pars plana vitrectomy with scleral buckle + perfluoropropane gas tamponade
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 560 people.
The study is currently expected to finish around July 2028.
The main measurement is taken over: Until final 1 year follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Single surgery anatomic success — measured over Until final 1 year follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05863312 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Pars plana vitrectomyProcedure
Pars plana vitrectomy will be performed in a standard fashion starting with central vitrectomy, then by localizing retinal breaks, and marking them with endodiathermy. Perfluorocarbon will be used to displace subretinal fluid which will be aspirated at its exit from the retinal break as much as possible and maximal vitreous base shaving will be performed in all cases. This will be followed by an air-fluid exchange. Use of cryotherapy to solidify the retina intraoperatively and use of internal limiting membrane peeling of the posterior pole will be at the discretion of the surgeon. In all cases, laser photocoagulation around retinal breaks, holes, areas of lattice degeneration, and posterior to sclerotomy sites will be done and then a 360° laser retinopexy will be performed at the surgeon's discretion and consisted of three rows of medium-white burns anterior to the level of the vortex vein, towards and beyond the equator.
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Pars plana vitrectomy with scleral buckleProcedure
In cases with SB, after 360° peritomy and dissection in 4 quadrants, a 41-circling band with 3082 sleeves (Labtician Ophthalmics, Oakville, ON Canada) will be used in all cases and fixed to the sclera at approximatively 11.5 mm from the limbus (or 5.5 from the insertion of rectus muscles) using partial thickness scleral tunnel or mattress sutures with 5.0 prolene or nylon performed in 4 quadrants depending on the surgeon preferences. Pars plana vitrectomy will then be performed as in the PPV only group.
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Sulfur hexafluoride gas tamponadeOther
At the end of the surgery, the eye is filled with sulfur hexafluoride gas tamponade.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Perfluoropropane gasOther
At the end of the surgery, the eye is filled with perfluoropropane gas tamponade.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Until final 1 year follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →.
The study as a whole is currently expected to finish around 2028-07.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 560 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Québec, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Background: Few large randomized controlled trials provide strong evidence to guide surgical repair of primary rhegmatogenous retinal detachment (RRD) repair. The purpose of this factorial, single-blind, randomized controlled trial is to analyze and compare the surgical outcomes, functional visual outcomes, complications, and quality of life associated with RRD repair using (A) pars plana vitrectomy only (PPV) or PPV with scleral buckle (PPV-SB) and (B) sulfur hexafluoride gas (SF6) or perfluoropropane gas (C3F8) tamponade. Methods: Eligible patients with moderately complex RRD will be randomized 1:1 to PPV or PPV-SB and 1:1 to SF6 or C3F8 gas tamponade. Approximately 560 patients will be recruited to be able to detect a difference of around 10% in SSAS rate between groups. Patients will be followed using multimodal imaging and quality of life questionnaires before and after the surgical repair until 1 year postoperative. The primary outcome will be single surgery anatomic success (SSAS), defined as absence of reoperation for recurrent RRD in the operating room. Secondary outcomes will be pinhole visual acuity (PHVA) at 8-10 weeks and 6 months, final best-corrected visual acuity (BCVA), final retina status (i.e., attached or detached), time to onset of RRD recurrence, severity and number of complications, and questionnaire results. Discussion: This will be the first 2 × 2 factorial randomized controlled trial examining repair techniques in primary RRD. It will also be the first randomized controlled trial to compare gas tamponade between the two most common agents. Notably, it will be adequately powered to detect a clinically significant effect size. The use of multimodal imaging will also be a novel aspect of this study, allowing us to compare head-to-head the impact of adding an SB to the retina's recovery after RRD repair and of differing gas tamponades. Until now, the treatment of RRD has been largely guided by pragmatic retrospective cohort studies. There is a lack of strong evidence guiding therapeutic decisions and this trial will address (1) whether supplemental SB is justified and (2) whether longer duration gas tamponade with C3F8 is necessary.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.