REtinal Detachment Outcomes Study
REDOS
Rhegmatogenous rEtinal Detachment With or withOut Scleral Buckle (REDOS) Trial: a Factorial, Randomized Controlled Trial
1 other identifier
interventional
560
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2023
CompletedFirst Posted
Study publicly available on registry
May 18, 2023
CompletedStudy Start
First participant enrolled
September 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
November 18, 2023
November 1, 2023
3.8 years
May 8, 2023
November 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Single surgery anatomic success
Freedom from reoperation for recurrent RRD
Until final 1 year follow-up
Secondary Outcomes (5)
Pinhole visual acuity
8-10 weeks, 6 months
Best-corrected visual acuity
1 year
Time to onset of RD recurrence
Until final 1 year follow-up
Severity and number of complications
Until final 1 year follow-up
Quality of life questionnaire
2 weeks, 8-10 weeks, 6 months, 12 months
Study Arms (4)
Pars plana vitrectomy + sulfur hexafluoride gas tamponade
ACTIVE COMPARATORPars plana vitrectomy with scleral buckle + sulfur hexafluoride gas tamponade
EXPERIMENTALPars plana vitrectomy + perfluoropropane gas tamponade
EXPERIMENTALPars plana vitrectomy with scleral buckle + perfluoropropane gas tamponade
EXPERIMENTALInterventions
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.
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.
At the end of the surgery, the eye is filled with sulfur hexafluoride gas tamponade.
At the end of the surgery, the eye is filled with perfluoropropane gas tamponade.
Eligibility Criteria
You may qualify if:
- Age ≥18 years
- Diagnosis of rhegmatogenous retinal detachment
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CHU de Quebec-Universite Lavallead
- Fighting Blindness Canadacollaborator
Study Sites (1)
Hôpital du Saint-Sacrement, CHU de Québec - Université Laval
Québec, Quebec, G1S4L8, Canada
Related Publications (1)
Hebert M, Bourgault S, Caissie M, Tourville E, Dirani A. REtinal Detachment Outcomes Study (REDOS): study protocol for a factorial, randomized controlled trial. Trials. 2023 Dec 20;24(1):820. doi: 10.1186/s13063-023-07815-x.
PMID: 38124155DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ali Dirani, MD MSc MPH
CHU de Québec - Université Laval
- PRINCIPAL INVESTIGATOR
Mélanie Hébert, MD MSc
CHU de Québec - Université Laval
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2023
First Posted
May 18, 2023
Study Start
September 26, 2023
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2028
Last Updated
November 18, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
The full protocol will be published in the journal Trials. The final trial dataset could be made available to other research teams upon reasonable request and after evaluation of the request by the trial team. The shared dataset will be coded and will not include any identifying patient data.