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REtinal Detachment Outcomes Study (REDOS)

Primary Purpose

Retinal Detachment

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pars plana vitrectomy
Pars plana vitrectomy with scleral buckle
Sulfur hexafluoride gas tamponade
Perfluoropropane gas
Sponsored by
CHU de Quebec-Universite Laval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Detachment focused on measuring Pars plana vitrectomy, Scleral buckle, Rhegmatogenous retinal detachment, Proliferative vitreoretinopathy, Anatomic success, Visual acuity, Retinal displacement, Postoperative pain, Quality of life, Complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hôpital du Saint-Sacrement, CHU de Québec - Université LavalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Pars plana vitrectomy + sulfur hexafluoride gas tamponade

Pars plana vitrectomy with scleral buckle + sulfur hexafluoride gas tamponade

Pars plana vitrectomy + perfluoropropane gas tamponade

Pars plana vitrectomy with scleral buckle + perfluoropropane gas tamponade

Arm Description

Outcomes

Primary Outcome Measures

Single surgery anatomic success
Freedom from reoperation for recurrent RRD

Secondary Outcome Measures

Pinhole visual acuity
Best-corrected visual acuity
Time to onset of RD recurrence
Severity and number of complications
Quality of life questionnaire

Full Information

First Posted
May 8, 2023
Last Updated
October 2, 2023
Sponsor
CHU de Quebec-Universite Laval
Collaborators
Fighting Blindness Canada
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1. Study Identification

Unique Protocol Identification Number
NCT05863312
Brief Title
REtinal Detachment Outcomes Study
Acronym
REDOS
Official Title
Rhegmatogenous rEtinal Detachment With or withOut Scleral Buckle (REDOS) Trial: a Factorial, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 26, 2023 (Actual)
Primary Completion Date
July 2027 (Anticipated)
Study Completion Date
July 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Quebec-Universite Laval
Collaborators
Fighting Blindness Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 3 months 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment
Keywords
Pars plana vitrectomy, Scleral buckle, Rhegmatogenous retinal detachment, Proliferative vitreoretinopathy, Anatomic success, Visual acuity, Retinal displacement, Postoperative pain, Quality of life, Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
560 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pars plana vitrectomy + sulfur hexafluoride gas tamponade
Arm Type
Active Comparator
Arm Title
Pars plana vitrectomy with scleral buckle + sulfur hexafluoride gas tamponade
Arm Type
Experimental
Arm Title
Pars plana vitrectomy + perfluoropropane gas tamponade
Arm Type
Experimental
Arm Title
Pars plana vitrectomy with scleral buckle + perfluoropropane gas tamponade
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Pars plana vitrectomy
Other Intervention Name(s)
PPV
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Pars plana vitrectomy with scleral buckle
Other Intervention Name(s)
PPV-SB
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sulfur hexafluoride gas tamponade
Other Intervention Name(s)
SF6
Intervention Description
At the end of the surgery, the eye is filled with sulfur hexafluoride gas tamponade.
Intervention Type
Other
Intervention Name(s)
Perfluoropropane gas
Other Intervention Name(s)
C3F8
Intervention Description
At the end of the surgery, the eye is filled with perfluoropropane gas tamponade.
Primary Outcome Measure Information:
Title
Single surgery anatomic success
Description
Freedom from reoperation for recurrent RRD
Time Frame
Until final 1 year follow-up
Secondary Outcome Measure Information:
Title
Pinhole visual acuity
Time Frame
3 months, 6 months
Title
Best-corrected visual acuity
Time Frame
1 year
Title
Time to onset of RD recurrence
Time Frame
Until final 1 year follow-up
Title
Severity and number of complications
Time Frame
Until final 1 year follow-up
Title
Quality of life questionnaire
Time Frame
2 weeks, 8-10 weeks, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Mauger, BSc
Phone
418-682-7511
Ext
84821
Email
cuo.recherche@fmed.ulaval.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Dirani, MD MSc MPH
Organizational Affiliation
CHU de Québec - Université Laval
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mélanie Hébert, MD MSc
Organizational Affiliation
CHU de Québec - Université Laval
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital du Saint-Sacrement, CHU de Québec - Université Laval
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1S4L8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Mauger

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

REtinal Detachment Outcomes Study

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