REtinal Detachment Outcomes Study (REDOS)

November 17, 2023 updated by: CHU de Quebec-Universite Laval

Rhegmatogenous rEtinal Detachment With or withOut Scleral Buckle (REDOS) Trial: a Factorial, Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

560

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1S4L8
        • Recruiting
        • Hôpital du Saint-Sacrement, CHU de Québec - Université Laval
        • Contact:
          • Julie Mauger

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pars plana vitrectomy + sulfur hexafluoride gas tamponade
Procedure: Pars plana vitrectomy
Pars plana vitrectomy will be performed in a standard fashion starting with central vitrectomy, then by localizing retinal breaks, and marking them with endodiathermy. Perfluorocarbon will be used to displace subretinal fluid which will be aspirated at its exit from the retinal break as much as possible and maximal vitreous base shaving will be performed in all cases. This will be followed by an air-fluid exchange. Use of cryotherapy to solidify the retina intraoperatively and use of internal limiting membrane peeling of the posterior pole will be at the discretion of the surgeon. In all cases, laser photocoagulation around retinal breaks, holes, areas of lattice degeneration, and posterior to sclerotomy sites will be done and then a 360° laser retinopexy will be performed at the surgeon's discretion and consisted of three rows of medium-white burns anterior to the level of the vortex vein, towards and beyond the equator.
Other Names:
  • PPV
Other: Sulfur hexafluoride gas tamponade
At the end of the surgery, the eye is filled with sulfur hexafluoride gas tamponade.
Other Names:
  • SF6
Experimental: Pars plana vitrectomy with scleral buckle + sulfur hexafluoride gas tamponade
Other: Sulfur hexafluoride gas tamponade
At the end of the surgery, the eye is filled with sulfur hexafluoride gas tamponade.
Other Names:
  • SF6
Procedure: Pars plana vitrectomy with scleral buckle
In cases with SB, after 360° peritomy and dissection in 4 quadrants, a 41-circling band with 3082 sleeves (Labtician Ophthalmics, Oakville, ON Canada) will be used in all cases and fixed to the sclera at approximatively 11.5 mm from the limbus (or 5.5 from the insertion of rectus muscles) using partial thickness scleral tunnel or mattress sutures with 5.0 prolene or nylon performed in 4 quadrants depending on the surgeon preferences. Pars plana vitrectomy will then be performed as in the PPV only group.
Other Names:
  • PPV-SB
Experimental: Pars plana vitrectomy + perfluoropropane gas tamponade
Procedure: Pars plana vitrectomy
Pars plana vitrectomy will be performed in a standard fashion starting with central vitrectomy, then by localizing retinal breaks, and marking them with endodiathermy. Perfluorocarbon will be used to displace subretinal fluid which will be aspirated at its exit from the retinal break as much as possible and maximal vitreous base shaving will be performed in all cases. This will be followed by an air-fluid exchange. Use of cryotherapy to solidify the retina intraoperatively and use of internal limiting membrane peeling of the posterior pole will be at the discretion of the surgeon. In all cases, laser photocoagulation around retinal breaks, holes, areas of lattice degeneration, and posterior to sclerotomy sites will be done and then a 360° laser retinopexy will be performed at the surgeon's discretion and consisted of three rows of medium-white burns anterior to the level of the vortex vein, towards and beyond the equator.
Other Names:
  • PPV
Other: Perfluoropropane gas
At the end of the surgery, the eye is filled with perfluoropropane gas tamponade.
Other Names:
  • C3F8
Experimental: Pars plana vitrectomy with scleral buckle + perfluoropropane gas tamponade
Procedure: Pars plana vitrectomy with scleral buckle
In cases with SB, after 360° peritomy and dissection in 4 quadrants, a 41-circling band with 3082 sleeves (Labtician Ophthalmics, Oakville, ON Canada) will be used in all cases and fixed to the sclera at approximatively 11.5 mm from the limbus (or 5.5 from the insertion of rectus muscles) using partial thickness scleral tunnel or mattress sutures with 5.0 prolene or nylon performed in 4 quadrants depending on the surgeon preferences. Pars plana vitrectomy will then be performed as in the PPV only group.
Other Names:
  • PPV-SB
Other: Perfluoropropane gas
At the end of the surgery, the eye is filled with perfluoropropane gas tamponade.
Other Names:
  • C3F8

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Single surgery anatomic success
Time Frame: Until final 1 year follow-up
Freedom from reoperation for recurrent RRD
Until final 1 year follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Best-corrected visual acuity
Time Frame: 1 year
1 year
Time to onset of RD recurrence
Time Frame: Until final 1 year follow-up
Until final 1 year follow-up
Severity and number of complications
Time Frame: Until final 1 year follow-up
Until final 1 year follow-up
Quality of life questionnaire
Time Frame: 2 weeks, 8-10 weeks, 6 months, 12 months
2 weeks, 8-10 weeks, 6 months, 12 months
Pinhole visual acuity
Time Frame: 8-10 weeks, 6 months
8-10 weeks, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Quebec-Universite Laval

Collaborators

Fighting Blindness Canada

Investigators

  • Principal Investigator: Ali Dirani, MD MSc MPH, CHU de Québec - Université Laval
  • Principal Investigator: Mélanie Hébert, MD MSc, CHU de Québec - Université Laval

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2023

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

May 8, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

November 18, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-6508

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The full protocol will be published in the journal Trials. The final trial dataset could be made available to other research teams upon reasonable request and after evaluation of the request by the trial team. The shared dataset will be coded and will not include any identifying patient data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Retinal Detachment

Clinical Trials on Pars plana vitrectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe