Trials · 2025
Conventional probe trabeculotomy versus microcatheter-assisted 360° trabeculotomy (PIRATE) in childhood glaucoma-study protocol for a randomized controlled trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Stingl Julia V, Schmidtmann Irene M, Schepers Markus, Schuster Alexander K, Rezapour Jasmin, Welzel Anna M, Mendoza-Moreira Angi L, Elflein Heike, Ehrlich Anne, Wolf Claudia, Hopp Michael, Stalmans Ingeborg, Lemmens Sophie, Dietlein Thomas, Schrittenlocher Silvia, Lappas Alexandra, Schuart Claudia, Thieme Hagen, Hoffmann Esther M
Аннотация
BACKGROUND: To compare the success and safety of microcatheter-assisted 360° trabeculotomy (MCAT) with conventional probe trabeculotomy in a large, heterogeneous cohort of children with primary or secondary glaucoma.
METHODS: In this prospective, multicenter, observer-blinded, randomized controlled trial, 76 children (152 eyes) with bilateral primary or secondary childhood glaucoma aged ≤ 12 years will be included. Each child acts as own control using a paired-eye design: One eye is allocated to MCAT (experimental intervention), achieving a 360° trabeculotomy, the other eye to the probe trabeculotomy (control intervention) which enables a trabeculotomy over 90 to 120°. Each child receives both procedures (paired-eye design). The worse eye is treated first; the surgical method is randomized. Patients and observers are masked to the procedures. The patients are followed up for 24 months. The primary endpoint is complete success (IOP < 18 mmHg at 24 months without medication and revision surgery; with MCAT: successful probing of > 120° is also required for success) at 24 months of follow-up. The primary analysis is performed in the intention-to-treat population using McNemar test stratified by center.
DISCUSSION: The PIRATE study is a multicenter randomized controlled study comparing MCAT with conventional probe trabeculotomy in a large and heterogeneous childhood glaucoma population. It will provide data on the success and safety of both techniques and clarify if MCAT is superior to probe trabeculotomy.
TRIAL REGISTRATION: German Clinical Trials Register, DRKS-ID: DRKS00034139. Registered on April 24, 2024. https://drks.de/search/en/trial/DRKS00034139 . https://trialsearch.who.int/Trial2.aspx?TrialID=DRKS00034139 .
METHODS: In this prospective, multicenter, observer-blinded, randomized controlled trial, 76 children (152 eyes) with bilateral primary or secondary childhood glaucoma aged ≤ 12 years will be included. Each child acts as own control using a paired-eye design: One eye is allocated to MCAT (experimental intervention), achieving a 360° trabeculotomy, the other eye to the probe trabeculotomy (control intervention) which enables a trabeculotomy over 90 to 120°. Each child receives both procedures (paired-eye design). The worse eye is treated first; the surgical method is randomized. Patients and observers are masked to the procedures. The patients are followed up for 24 months. The primary endpoint is complete success (IOP < 18 mmHg at 24 months without medication and revision surgery; with MCAT: successful probing of > 120° is also required for success) at 24 months of follow-up. The primary analysis is performed in the intention-to-treat population using McNemar test stratified by center.
DISCUSSION: The PIRATE study is a multicenter randomized controlled study comparing MCAT with conventional probe trabeculotomy in a large and heterogeneous childhood glaucoma population. It will provide data on the success and safety of both techniques and clarify if MCAT is superior to probe trabeculotomy.
TRIAL REGISTRATION: German Clinical Trials Register, DRKS-ID: DRKS00034139. Registered on April 24, 2024. https://drks.de/search/en/trial/DRKS00034139 . https://trialsearch.who.int/Trial2.aspx?TrialID=DRKS00034139 .