Retinal DetachmentREDOSNCT05863312
REtinal Detachment Outcomes Study
A study testing Pars plana vitrectomy, Pars plana vitrectomy with scleral buckle and Sulfur hexafluoride gas tamponade in people with Retinal Detachment, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- Pars plana vitrectomy, Pars plana vitrectomy with scleral buckle and Sulfur hexafluoride gas tamponade
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteCanada
- Study dates
- 26 Sep 2023to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Diagnosis of rhegmatogenous retinal detachment
Who cannot join
- 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
Show all 18Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Hôpital du Saint-Sacrement, CHU de Québec - Université Laval
Québec, Quebec, G1S4L8
Julie Mauger
About this study
Official title: 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.
- Conditions
- Retinal Detachment
- Being tested
- Pars plana vitrectomy, Pars plana vitrectomy with scleral buckle, Sulfur hexafluoride gas tamponade, Perfluoropropane gas
- Keywords
- Pars plana vitrectomy, Scleral buckle, Rhegmatogenous retinal detachment, Proliferative vitreoretinopathy, Anatomic success, Visual acuity, Retinal displacement, Postoperative pain, Quality of life, Complications
- Medical subject headings
- Retinal Detachment, Vitreoretinopathy, Proliferative, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pars plana vitrectomyProcedure or surgery
Also called PPV
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.
Pars plana vitrectomy with scleral buckleProcedure or surgery
Also called PPV-SB
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.
Sulfur hexafluoride gas tamponadeOther
Also called SF6
At the end of the surgery, the eye is filled with sulfur hexafluoride gas tamponade.
Perfluoropropane gasOther
Also called C3F8
At the end of the surgery, the eye is filled with perfluoropropane gas tamponade.
| Study group | Role | What they receive |
|---|---|---|
| Pars plana vitrectomy + sulfur hexafluoride gas tamponade | Active comparator | Not described Receives: Procedure: Pars plana vitrectomy; Other: Sulfur hexafluoride gas tamponade |
| Pars plana vitrectomy with scleral buckle + sulfur hexafluoride gas tamponade | Experimental | Not described Receives: Procedure: Pars plana vitrectomy with scleral buckle; Other: Sulfur hexafluoride gas tamponade |
| Pars plana vitrectomy + perfluoropropane gas tamponade | Experimental | Not described Receives: Procedure: Pars plana vitrectomy; Other: Perfluoropropane gas |
| Pars plana vitrectomy with scleral buckle + perfluoropropane gas tamponade | Experimental | Not described Receives: Procedure: Pars plana vitrectomy with scleral buckle; Other: Perfluoropropane gas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single surgery anatomic success
Freedom from reoperation for recurrent RRD
Measured: Until final 1 year follow-up
Secondary outcomes (5)
Pinhole visual acuity
Measured: 8-10 weeks, 6 months
Best-corrected visual acuity
Measured: 1 year
Time to onset of RD recurrence
Measured: Until final 1 year follow-up
Severity and number of complications
Measured: Until final 1 year follow-up
Quality of life questionnaire
Measured: 2 weeks, 8-10 weeks, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start26 Sep 2023
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- Fighting Blindness Canada
- Responsible party
- Sponsor
- Investigators
- Ali Dirani, MD MSc MPH, Principal investigator, CHU de Québec - Université LavalMélanie Hébert, MD MSc, Principal investigator, CHU de Québec - Université Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863312
- Sponsor's protocol ID
- 2023-6508
- Acronym
- REDOS
- Status last verified
- Nov 2023
- First submitted
- 8 May 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Hebert M, Bourgault S, Caissie M, Tourville E, Dirani A. REtinal Detachment Outcomes Study (REDOS): study protocol for a factorial, randomized controlled trial. Trials. 2023 Dec 20;24(1):820. doi: 10.1186/s13063-023-07815-x.
PubMed 38124155
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rhegmatogenous rEtinal Detachment With or withOut Scleral Buckle (REDOS) Trial: a Factorial, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05863312
- Acronym / sponsor ID
- REDOS / 2023-6508
- Conditions
- Retinal Detachment
- Keywords
- Pars plana vitrectomy, Scleral buckle, Rhegmatogenous retinal detachment, Proliferative vitreoretinopathy, Anatomic success, Visual acuity, Retinal displacement, Postoperative pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- Fighting Blindness Canada
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pars plana vitrectomy + sulfur hexafluoride gas tamponade | Active comparator | Procedure: Pars plana vitrectomy, Other: Sulfur hexafluoride gas tamponade |
| Pars plana vitrectomy with scleral buckle + sulfur hexafluoride gas tamponade | Experimental | Procedure: Pars plana vitrectomy with scleral buckle, Other: Sulfur hexafluoride gas tamponade |
| Pars plana vitrectomy + perfluoropropane gas tamponade | Experimental | Procedure: Pars plana vitrectomy, Other: Perfluoropropane gas |
| Pars plana vitrectomy with scleral buckle + perfluoropropane gas tamponade | Experimental | Procedure: Pars plana vitrectomy with scleral buckle, Other: Perfluoropropane gas |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥18 years
- Diagnosis of rhegmatogenous retinal detachment
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pars plana vitrectomyAlso: PPVPars 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. | Procedure or surgery | Pars plana vitrectomy + perfluoropropane gas tamponade, Pars plana vitrectomy + sulfur hexafluoride gas tamponade |
| Pars plana vitrectomy with scleral buckleAlso: PPV-SBIn 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. | Procedure or surgery | Pars plana vitrectomy with scleral buckle + perfluoropropane gas tamponade, Pars plana vitrectomy with scleral buckle + sulfur hexafluoride gas tamponade |
| Sulfur hexafluoride gas tamponadeAlso: SF6At the end of the surgery, the eye is filled with sulfur hexafluoride gas tamponade. | Other | Pars plana vitrectomy + sulfur hexafluoride gas tamponade, Pars plana vitrectomy with scleral buckle + sulfur hexafluoride gas tamponade |
| Perfluoropropane gasAlso: C3F8At the end of the surgery, the eye is filled with perfluoropropane gas tamponade. | Other | Pars plana vitrectomy + perfluoropropane gas tamponade, Pars plana vitrectomy with scleral buckle + perfluoropropane gas tamponade |
Primary outcome
Single surgery anatomic success
Time frame: Until final 1 year follow-up
Freedom from reoperation for recurrent RRD
5 secondary outcomes
Pinhole visual acuity
Time frame: 8-10 weeks, 6 months
Best-corrected visual acuity
Time frame: 1 year
Time to onset of RD recurrence
Time frame: Until final 1 year follow-up
Severity and number of complications
Time frame: Until final 1 year follow-up
Quality of life questionnaire
Time frame: 2 weeks, 8-10 weeks, 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 38124155Hebert M, Bourgault S, Caissie M, Tourville E, Dirani A. REtinal Detachment Outcomes Study (REDOS): study protocol for a factorial, randomized controlled trial. Trials. 2023 Dec 20;24(1):820. doi: 10.1186/s13063-023-07815-x.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ali Dirani, MD MSc MPH principal investigator
CHU de Québec - Université Laval
Mélanie Hébert, MD MSc principal investigator
CHU de Québec - Université Laval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pars plana vitrectomy, Pars plana vitrectomy with scleral buckle and Sulfur hexafluoride gas tamponade in people with Retinal Detachment, run by CHU de Quebec-Universite Laval at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Mauger, BSc (418-682-7511 ext. 84821, cuo.recherche@fmed.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single surgery anatomic success (time frame: Until final 1 year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05863312, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.