Clinical trial NCT05863312: REtinal Detachment Outcomes Study
Official title: Rhegmatogenous rEtinal Detachment With or withOut Scleral Buckle (REDOS) Trial: a Factorial, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Retinal Detachment
Keywords: Pars plana vitrectomy
Scleral buckle
Rhegmatogenous retinal detachment
Proliferative vitreoretinopathy
Anatomic success
Visual acuity
Retinal displacement
Postoperative pain
Quality of life
Complications
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: Fighting Blindness Canada
First posted: 2023-05-18
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Single surgery anatomic success
timeFrame: Until final 1 year follow-up
Secondary outcomes:
measure: Pinhole visual acuity
timeFrame: 8-10 weeks, 6 months
measure: Best-corrected visual acuity
timeFrame: 1 year
measure: Time to onset of RD recurrence
timeFrame: Until final 1 year follow-up
measure: Severity and number of complications
timeFrame: Until final 1 year follow-up
measure: Quality of life questionnaire
timeFrame: 2 weeks, 8-10 weeks, 6 months, 12 months
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Hôpital du Saint-Sacrement, CHU de Québec - Université Laval
state: Quebec
Study officials:
affiliation: CHU de Québec - Université Laval
name: Ali Dirani, MD MSc MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Québec - Université Laval
name: Mélanie Hébert, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: