Studio sui risultati del distacco retinico (REDOS)
Prova di distacco retinico regmatogeno con o senza fibbia sclerale (REDOS): uno studio fattoriale controllato randomizzato
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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Julie Mauger, BSc
- Numero di telefono: 84821 418-682-7511
- Email: cuo.recherche@fmed.ulaval.ca
Luoghi di studio
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Quebec
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Québec, Quebec, Canada, G1S4L8
- Reclutamento
- Hôpital du Saint-Sacrement, CHU de Québec - Université Laval
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Contatto:
- Julie Mauger
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione fattoriale
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Vitrectomia su pars plana + tamponamento con gas esafluoruro di zolfo
|
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.
Altri nomi:
At the end of the surgery, the eye is filled with sulfur hexafluoride gas tamponade.
Altri nomi:
|
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Sperimentale: Vitrectomia su pars plana con fibbia sclerale + tamponamento con gas esafluoruro di zolfo
|
At the end of the surgery, the eye is filled with sulfur hexafluoride gas tamponade.
Altri nomi:
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.
Altri nomi:
|
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Sperimentale: Vitrectomia su pars plana + tamponamento con gas perfluoropropano
|
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.
Altri nomi:
At the end of the surgery, the eye is filled with perfluoropropane gas tamponade.
Altri nomi:
|
|
Sperimentale: Vitrectomia su pars plana con fibbia sclerale + tamponamento con gas perfluoropropano
|
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.
Altri nomi:
At the end of the surgery, the eye is filled with perfluoropropane gas tamponade.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Single surgery anatomic success
Lasso di tempo: Until final 1 year follow-up
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Freedom from reoperation for recurrent RRD |
Until final 1 year follow-up
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Acuità visiva meglio corretta
Lasso di tempo: 1 anno
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1 anno
|
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Tempo di insorgenza della recidiva di RD
Lasso di tempo: Fino al follow-up finale di 1 anno
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Fino al follow-up finale di 1 anno
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Gravità e numero di complicanze
Lasso di tempo: Fino al follow-up finale di 1 anno
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Fino al follow-up finale di 1 anno
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Questionario sulla qualità della vita
Lasso di tempo: 2 settimane, 8-10 settimane, 6 mesi, 12 mesi
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2 settimane, 8-10 settimane, 6 mesi, 12 mesi
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Acuità visiva stenopeica
Lasso di tempo: 8-10 settimane, 6 mesi
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8-10 settimane, 6 mesi
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Ali Dirani, MD MSc MPH, CHU de Québec - Université Laval
- Investigatore principale: Mélanie Hébert, MD MSc, CHU de Québec - Université Laval
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Dolore
- Manifestazioni neurologiche
- Complicanze postoperatorie
- Processi patologici
- Malattie degli occhi
- Malattie retiniche
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Dolore, Postoperatorio
- Distacco della retina
- Vitreoretinopatia, Proliferativa
- Procedure chirurgiche, operative
- Procedure chirurgiche oftalmologiche
- perflutren
- Scleral Buckling
Altri numeri di identificazione dello studio
- 2023-6508
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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.
Informazioni su farmaci e dispositivi, documenti di studio
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