REtinal Detachment Outcomes Study (REDOS): study protocol for a factorial, randomized controlled trial.
Mélanie Hébert, Serge Bourgault, Mathieu Caissie...
https://pubmed.ncbi.nlm.nih.gov/38124155Actively Recruiting
Led by CHU de Quebec-Universite Laval · Updated on 2023-11-18
560
Participants Needed
1
Research Sites
52 weeks
Total Duration
C
CHU de Quebec-Universite Laval
Lead Sponsor
F
Fighting Blindness Canada
Collaborating Sponsor
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
REtinal Detachment Outcomes Study
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 1 location
1
Hôpital du Saint-Sacrement, CHU de Québec - Université Laval
Québec, Quebec, Canada, G1S4L8
Actively Recruiting
J
Julie Mauger, BSc
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Mélanie Hébert, Serge Bourgault, Mathieu Caissie...
https://pubmed.ncbi.nlm.nih.gov/38124155