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REtinal Detachment Outcomes Study

RecruitingNAAges 18 Years - anyAllCHU de Quebec-Universite Laval
NCT05863312 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 surgica

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📋 Eligibility rules (as published)
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)
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What it tests

  • Pars plana vitrectomy
  • Pars plana vitrectomy with scleral buckle
  • Sulfur hexafluoride gas tamponade
  • Perfluoropropane gas
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Where

1 site
Hôpital du Saint-Sacrement, CHU de Québec - Université Laval
Québec, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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