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REtinal Detachment Outcomes Study (REDOS): study protocol for a factorial, randomized controlled trial.

Mélanie Hébert1, Serge Bourgault1, Mathieu Caissie1

  • 1Department of Ophthalmology, Hôpital du Saint-Sacrement, CHU de Québec - Université Laval, 1050 Ch Ste-Foy Street, Québec, QC, G1S 4L8, Canada.

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Summary
This summary is machine-generated.

This trial compares pars plana vitrectomy (PPV) with or without scleral buckle (SB) and two gases for rhegmatogenous retinal detachment (RRD) repair. It aims to provide evidence for optimal surgical techniques and gas tamponade in RRD treatment.

Keywords:
Anatomic successComplicationsPars plana vitrectomyPostoperative painProliferative vitreoretinopathyQuality of lifeRetinal displacementRhegmatogenous retinal detachmentScleral buckleVisual acuity

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Area of Science:

  • Ophthalmology
  • Retinal Surgery
  • Clinical Trials

Background:

  • Limited high-quality evidence exists for primary rhegmatogenous retinal detachment (RRD) surgical repair.
  • Current treatment decisions often rely on retrospective data, necessitating robust randomized controlled trials.

Purpose of the Study:

  • To compare surgical outcomes, visual function, complications, and quality of life for RRD repair using pars plana vitrectomy (PPV) alone versus PPV with scleral buckle (PPV-SB).
  • To evaluate the efficacy of sulfur hexafluoride (SF6) gas versus perfluoropropane (C3F8) gas tamponade in RRD repair.

Main Methods:

  • A 2x2 factorial, single-blind, randomized controlled trial involving approximately 560 patients with moderately complex RRD.
  • Patients randomized to either PPV or PPV-SB and to either SF6 or C3F8 gas tamponade.
  • Primary outcome: single-surgery anatomic success (SSAS). Secondary outcomes include visual acuity, retina status, recurrence, complications, and quality of life.

Main Results:

  • This section is not yet available as the study is ongoing.
  • The trial is powered to detect a 10% difference in SSAS rates between groups.
  • Multimodal imaging and quality of life questionnaires will be utilized for comprehensive follow-up.

Conclusions:

  • This is the first 2x2 factorial RCT for primary RRD repair, comparing surgical techniques and common gas tamponades.
  • The study will provide crucial evidence on the justification of supplemental scleral buckle and the necessity of longer-duration gas tamponade.
  • Novel use of multimodal imaging will allow direct comparison of the impact of scleral buckle and different gas tamponades on retinal recovery.