Comparing surgical methods for retinal detachment repair
Rhegmatogenous rEtinal Detachment With or withOut Scleral Buckle (REDOS) Trial: a Factorial, Randomized Controlled Trial
This study is testing two different surgical methods for fixing retinal detachment to see which one works better for patients and how different types of gas used during surgery affect their recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 560 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CHU de Quebec-Universite Laval Academic / other |
| Locations | 1 site (Québec, Quebec) |
| Trial ID | NCT05863312 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to analyze and compare the surgical outcomes of two methods for repairing primary rhegmatogenous retinal detachment (RRD): pars plana vitrectomy (PPV) alone and PPV combined with scleral buckle (PPV-SB). Additionally, it will evaluate the effectiveness of two types of gas tamponade, sulfur hexafluoride (SF6) and perfluoropropane (C3F8). Approximately 560 eligible patients will be randomized to receive one of the surgical interventions and will be followed for one year post-surgery to assess anatomical success, visual outcomes, complications, and quality of life. The study seeks to provide robust evidence to guide surgical decisions in RRD repair.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with rhegmatogenous retinal detachment.
Not a fit: Patients with complex retinal conditions such as proliferative vitreoretinopathy or chronic retinal detachment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and quality of life for patients with retinal detachment.
How similar studies have performed: Previous studies have shown varying success with different surgical approaches for retinal detachment, but this specific factorial design is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Québec, Quebec
- Hôpital du Saint-Sacrement, CHU de Québec - Université Laval — Québec, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Ali Dirani, MD MSc MPH — CHU de Québec - Université Laval
- Study coordinator: Julie Mauger, BSc
- Email: cuo.recherche@fmed.ulaval.ca
- Phone: 418-682-7511
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.