REtinal Detachment Outcomes Study

Retinal Detachment Clinical Trial

— REDOS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05863312
• Other study ID #: 2023-6508
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2023
• Est. completion date: July 2028

Study information

• Verified date: November 2023
• Source: CHU de Quebec-Universite Laval
• Contact: Julie Mauger, BSc
• Phone: 418-682-7511
• Email: cuo.recherche[@]fmed.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 560
• Est. completion date: July 2028
• Est. primary completion date: July 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dissociative Disorders
• Retinal Detachment

Intervention

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

Locations

Country	Name	City	State
Canada	Hôpital du Saint-Sacrement, CHU de Québec - Université Laval	Québec	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval	Fighting Blindness Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Single surgery anatomic success	Freedom from reoperation for recurrent RRD	Until final 1 year follow-up
Secondary	Pinhole visual acuity		8-10 weeks, 6 months
Secondary	Best-corrected visual acuity		1 year
Secondary	Time to onset of RD recurrence		Until final 1 year follow-up
Secondary	Severity and number of complications		Until final 1 year follow-up
Secondary	Quality of life questionnaire		2 weeks, 8-10 weeks, 6 months, 12 months