Scholarlink

Background <p>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.</p> Methods <p>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 &lt; 18 mmHg at 24 months without medication and revision surgery; with MCAT: successful probing of &gt; 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.</p> Discussion <p>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.</p> Trial registration <p>German Clinical Trials Register, DRKS-ID: DRKS00034139. Registered on April 24, 2024. <a href="https://drks.de/search/en/trial/DRKS00034139">https://drks.de/search/en/trial/DRKS00034139</a>. <a href="https://trialsearch.who.int/Trial2.aspx?TrialID=DRKS00034139">https://trialsearch.who.int/Trial2.aspx?TrialID=DRKS00034139</a>.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Conventional probe trabeculotomy versus microcatheter-assisted 360° trabeculotomy (PIRATE) in childhood glaucoma—study protocol for a randomized controlled trial

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年9月22日

查看全文
  • Julia V. Stingl,
  • Irene M. Schmidtmann,
  • Markus Schepers,
  • Alexander K. Schuster,
  • Jasmin Rezapour,
  • Anna M. Welzel,
  • Angi L. Mendoza-Moreira,
  • Heike Elflein,
  • Anne Ehrlich,
  • Claudia Wolf,
  • Michael Hopp,
  • Ingeborg Stalmans,
  • Sophie Lemmens,
  • Thomas Dietlein,
  • Silvia Schrittenlocher,
  • Alexandra Lappas,
  • Claudia Schuart,
  • Hagen Thieme,
  • Esther M. Hoffmann

摘要

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.