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

Sponsor
Wuerzburg University Hospital
Study ID
NCT07780916
Status
Recruiting
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Conditions

  • GLAUCOMA 1, OPEN ANGLE, D (Disorder)
  • Glaucoma
  • Glaucoma Eye
  • Glaucoma Following Surgery
  • Glaucoma Patient

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ab-interno trabeculotomy — PROCEDURE
    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.

Study Details

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 Dates

First listed
Aug 24, 2026
Start date
Dec 3, 2025
Status verified
Aug 2026
Primary completion
Nov 1, 2026
Completion
Feb 1, 2027

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: AIT Cohort
    Tha AIT cohort consists of glaucoma patients who previously underwent ab-interno trabeculotomy (AIT) using the Trabectome device at the Department of Ophthalmology, University Hospital Würzburg. Participants are invited for a single follow-up visit to assess long-term intraocular pressure control, visual acuity, optic nerve status (OCT), and visual field outcomes compared to pre-operative baseline data obtained from medical records.

Primary Outcome Measure

Change in Intraocular Pressure (IOP) from Pre-operative Baseline to Follow-up [ Time Frame: From pre-operative baseline to single follow-up visit (minimum 4 years, up to 10 years post-surgery) ]

Central Contacts

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