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RECRUITING
NCT07780916

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

Sponsor: Wuerzburg University Hospital

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2025-12-03

Completion Date

2027-02-01

Last Updated

2026-08-25

Healthy Volunteers

No

Interventions

PROCEDURE

Ab-interno trabeculotomy

Ab-interno trabeculotomy (AIT) is a minimally invasive glaucoma surgery (MIGS) performed using the Trabectome device. The procedure ablates the trabecular meshwork and the inner wall of Schlemm's canal via an ab-interno approach, thereby reducing resistance to aqueous humor outflow and lowering intraocular pressure. The surgery is performed under local or general anesthesia and can be combined with cataract surgery. In this observational study, the intervention was performed prior to study enrollment; no surgical intervention is performed as part of the study itself.

Locations (1)

University Hospital Würzburg

Würzburg, Bavaria, Germany