REtinal Detachment Outcomes Study

Official title

Rhegmatogenous rEtinal Detachment With or withOut Scleral Buckle (REDOS) Trial: a Factorial, Randomized Controlled Trial

Overview

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.

Interventions

• 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 li
• 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 onl
• Other Sulfur hexafluoride gas tamponade
  At the end of the surgery, the eye is filled with sulfur hexafluoride gas tamponade.
• Other Perfluoropropane gas
  At the end of the surgery, the eye is filled with perfluoropropane gas tamponade.

Primary outcome measures

• Single surgery anatomic success [Time frame: Until final 1 year follow-up]

Secondary outcome measures (5)

• Pinhole visual acuity [Time frame: 8-10 weeks, 6 months]
• Best-corrected visual acuity [Time frame: 1 year]
• Time to onset of RD recurrence [Time frame: Until final 1 year follow-up]
• Severity and number of complications [Time frame: Until final 1 year follow-up]
• Quality of life questionnaire [Time frame: 2 weeks, 8-10 weeks, 6 months, 12 months]

Eligibility criteria

Inclusion criteria

• Age ≥18 years
• Diagnosis of rhegmatogenous retinal detachment

Exclusion Criteria, 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
• Prior glaucoma surgery or strabismus surgery (favoring PPV only)
• Superior RD extent less than 3 clock hours (favoring PPV only)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Factorial

Masking

Triple blind

Primary purpose

Treatment

Study locations

Canada · 1 center

• Hôpital du Saint-Sacrement, CHU de Québec - Université Laval — Québec

Publications

• 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 38124155

Identifiers

NCT: NCT05863312 · 2023-6508

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗