Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05863312

Rhegmatogenous Retinal Detachment With or Without Scleral Buckle Trial Comparing Gas Tamponades

Led by CHU de Quebec-Universite Laval · Updated on 2023-11-18

560

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

C

CHU de Quebec-Universite Laval

Lead Sponsor

F

Fighting Blindness Canada

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to compare different surgical methods and gas types used to repair primary rhegmatogenous retinal detachment (RRD), a condition where the retina detaches from the back of the eye. The study will evaluate how well each surgery works in preventing the need for additional operations, as well as assess visual function, complications, and quality of life after surgery. It is a single-blind, randomized controlled trial involving about 560 patients with moderately complex RRD. Participants will be randomly assigned to one of four groups in a 2x2 factorial design: pars plana vitrectomy (PPV) alone or PPV combined with scleral buckle (PPV-SB), and sulfur hexafluoride gas (SF6) or perfluoropropane gas (C3F8) used as tamponade. The PPV procedure involves removing the vitreous gel and treating retinal breaks, while the PPV-SB group also receives a scleral buckle to support the retina. At the end of surgery, the eye is filled with one of the two gases to help keep the retina in place. Participants will be followed for one year after surgery with multiple visits to assess anatomical success, measured by the absence of repeat surgery, as well as visual acuity at 8-10 weeks and 6 months, final visual outcomes, time to any retinal detachment recurrence, complications, and quality of life via questionnaires. Imaging will be used throughout to monitor recovery. This study will provide detailed insights into which surgical and gas tamponade techniques lead to better eye outcomes and patient experiences.

CONDITIONS

Brief Title

REtinal Detachment Outcomes Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of rhegmatogenous retinal detachment
Not Eligible

You will not qualify if you...

  • Proliferative vitreoretinopathy grade C2 or higher
  • Chronic retinal detachment lasting more than 3 months
  • Proliferative diabetic retinopathy with tractional retinal detachment
  • Presence of macular holes
  • Epiretinal membrane grade 3 or 4
  • Traumatic retinal detachment
  • 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
  • Superior retinal detachment extent less than 3 clock hours

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to 2 weeks or until discharge

Participants undergo pars plana vitrectomy with or without scleral buckle and receive gas tamponade as part of the surgical treatment for retinal detachment.

1 surgery visit and several immediate post-operative visits

Post-operative Follow-up

Duration - Up to 12 months

Participants attend follow-up visits to monitor recovery, visual acuity, and any complications after surgery.

Visits at 2 weeks, 8-10 weeks, 6 months, and 12 months

Trial Site Locations

Total: 1 location

1

Hôpital du Saint-Sacrement, CHU de Québec - Université Laval

Québec, Quebec, Canada, G1S4L8

Actively Recruiting

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Research Team

J

Julie Mauger, BSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

4

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