| NCT ID | NCT05863312 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CHU de Quebec-Universite Laval |
| Condition | Retinal Detachment |
| Study Type | INTERVENTIONAL |
| Enrollment | 560 participants |
| Start Date | 2023-09-26 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 560 participants in total. It began in 2023-09-26 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 surgical repair until 1 year postoperative. The primary outcome will be single surgery anatomic success (SSAS), defined as absence of reoperation for recurrent RRD in the operating room. Secondary outcomes will be pinhole visual acuity (PHVA) at 8-10 weeks and 6 months, final best-corrected visual acuity (BCVA), final retina status (i.e., attached or detached), time to onset of RRD recurrence, severity and number of complications, and questionnaire results. Discussion: This will be the first 2 × 2 factorial randomized controlled trial examining repair techniques in primary RRD. It will also be the first randomized controlled trial to compare gas tamponade between the two most common agents. Notably, it will be adequately powered to detect a clinically significant effect size. The use of multimodal imaging will also be a novel aspect of this study, allowing us to compare head-to-head the impact of adding an SB to the retina's recovery after RRD repair and of differing gas tamponades. Until now, the treatment of RRD has been largely guided by pragmatic retrospective cohort studies. There is a lack of strong evidence guiding therapeutic decisions and this trial will address (1) whether supplemental SB is justified and (2) whether longer duration gas tamponade with C3F8 is necessary.
Eligibility 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)
Contact & Investigator
Ali Dirani, MD MSc MPH
PRINCIPAL INVESTIGATOR
CHU de Québec - Université Laval
Frequently Asked Questions
Who can join the NCT05863312 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Retinal Detachment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05863312 currently recruiting?
Yes, NCT05863312 is actively recruiting participants. Contact the research team at cuo.recherche@fmed.ulaval.ca for enrollment information.
Where is the NCT05863312 trial being conducted?
This trial is being conducted at Québec, Canada.
Who is sponsoring the NCT05863312 clinical trial?
NCT05863312 is sponsored by CHU de Quebec-Universite Laval. The principal investigator is Ali Dirani, MD MSc MPH at CHU de Québec - Université Laval. The trial plans to enroll 560 participants.