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Long-Term Clinical Results of Ab-Interno Trabeculotomy in Glaucoma Management

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Minor Secondary endpoints: details revised at 4 of 4 entries
    • Eligibility criteria shortened, about 2 words
    • Study description expanded, about 2 words
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Glaucoma is one of the leading causes of irreversible vision loss worldwide. Elevated intraocular pressure (IOP) is the most important risk factor for the development and progression of the disease. Ab-interno trabeculotomy (AIT) using the Trabectome system is a minimally invasive glaucoma surgery (MIGS) that reduces aqueous humor outflow resistance by ablating the trabecular meshwork and the inner wall of Schlemm's canal, thereby lowering intraocular pressure. Previous studies have demonstrated good short-term efficacy of this procedure. However, robust long-term data spanning several years remain scarce. The aim of this study is to evaluate the long-term outcomes of AIT in glaucoma patients who underwent surgery between 2019 and 2021 at the Department of Ophthalmology, University Hospital Würzburg. Patients are invited for a single study visit at which intraocular pressure, visual acuity, anterior chamber angle by gonioscopy, and optic nerve structure by optical coherence tomography (OCT) are assessed. The collected data are compared with pre-operative baseline values obtained from medical records. The results are intended to improve the assessment of long-term surgical success and to optimize patient selection for this procedure in the future.
Trial Details
NCT Number NCT07780916
Lead Sponsor Wuerzburg University Hospital
Conditions
(from sponsor)
Glaucoma, Glaucoma Patient, GLAUCOMA 1, OPEN ANGLE, D (Disorder), Glaucoma Following Surgery, Glaucoma Eye
Related terms Glaucoma
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov