Studie zu den Ergebnissen einer Netzhautablösung (REDOS)
Studie zur rhegmatogenen Netzhautablösung mit oder ohne Skleralschnalle (REDOS): eine faktorielle, randomisierte kontrollierte Studie
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.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Julie Mauger, BSc
- Telefonnummer: 84821 418-682-7511
- E-Mail: cuo.recherche@fmed.ulaval.ca
Studienorte
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Quebec
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Québec, Quebec, Kanada, G1S4L8
- Rekrutierung
- Hôpital du Saint-Sacrement, CHU de Québec - Université Laval
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Kontakt:
- Julie Mauger
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Fakultätszuweisung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: Pars-plana-Vitrektomie + Schwefelhexafluorid-Gastamponade
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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.
Andere Namen:
At the end of the surgery, the eye is filled with sulfur hexafluoride gas tamponade.
Andere Namen:
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Experimental: Pars-plana-Vitrektomie mit Skleraschnalle + Schwefelhexafluorid-Gastamponade
|
At the end of the surgery, the eye is filled with sulfur hexafluoride gas tamponade.
Andere Namen:
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.
Andere Namen:
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Experimental: Pars-Plana-Vitrektomie + Perfluorpropan-Gas-Tamponade
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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.
Andere Namen:
At the end of the surgery, the eye is filled with perfluoropropane gas tamponade.
Andere Namen:
|
|
Experimental: Pars-plana-Vitrektomie mit Skleraschnalle + Perfluorpropan-Gastamponade
|
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.
Andere Namen:
At the end of the surgery, the eye is filled with perfluoropropane gas tamponade.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Single surgery anatomic success
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Bestmöglich korrigierte Sehschärfe
Zeitfenster: 1 Jahr
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1 Jahr
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Zeit bis zum Auftreten eines RD-Rezidivs
Zeitfenster: Bis zum letzten 1-Jahres-Follow-up
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Bis zum letzten 1-Jahres-Follow-up
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Schweregrad und Anzahl der Komplikationen
Zeitfenster: Bis zum letzten 1-Jahres-Follow-up
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Bis zum letzten 1-Jahres-Follow-up
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Fragebogen zur Lebensqualität
Zeitfenster: 2 Wochen, 8-10 Wochen, 6 Monate, 12 Monate
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2 Wochen, 8-10 Wochen, 6 Monate, 12 Monate
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Lochkamera-Sehschärfe
Zeitfenster: 8-10 Wochen, 6 Monate
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8-10 Wochen, 6 Monate
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Ali Dirani, MD MSc MPH, CHU de Québec - Université Laval
- Hauptermittler: Mélanie Hébert, MD MSc, CHU de Québec - Université Laval
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Schmerzen
- Neurologische Manifestationen
- Postoperative Komplikationen
- Pathologische Prozesse
- Augenkrankheiten
- Erkrankungen der Netzhaut
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Schmerzen, postoperativ
- Netzhautablösung
- Vitreoretinopathie, proliferativ
- Chirurgische Eingriffe, operativ
- Ophthalmologische chirurgische Eingriffe
- Perflutren
- Scleral Buckling
Andere Studien-ID-Nummern
- 2023-6508
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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