Long-Term Clinical Results of Ab-Interno Trabeculotomy in Glaucoma Management | NCT07780916 | Trialant

RecruitingObservationalUpdated Aug 25, 2026

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

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07780916
Lead Sponsor: Wuerzburg University HospitalOTHER
Overall Status: Recruiting
Study Type: Observational
Enrollment: 200Estimated
Last Update Posted: Aug 25, 2026Actual
Start Date: Dec 3, 2025Actual
Primary Completion Date: Nov 1, 2026Estimated
Completion Date: Feb 1, 2027Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: Long-Term Clinical Results of Ab-Interno Trabeculotomy in Glaucoma Management
Brief 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.

Conditions

The medical conditions and diseases this study investigates.

Glaucoma
Glaucoma Patient
GLAUCOMA 1, OPEN ANGLE, D (Disorder)

Interventions

The treatments and procedures being evaluated in this study.

Ab-interno trabeculotomy

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Diagnosis of glaucoma

Previous ab-interno trabeculotomy (AIT) using the Trabectome device performed at the Department of Ophthalmology, University Hospital Würzburg

Surgery performed between 2019 and 2021

Ability to provide written informed consent

Age ≥ 18 years at time of surgery

Exclusion Criteria:

Inability to attend the study visit

Withdrawal of informed consent

Insufficient medical records for pre-operative baseline data retrieval

Design

How the study is designed and how its participant groups are organized.

Observational Model: Cohort
Time Perspective: Prospective

Contacts

The people to reach with questions about this study or how to join it.

Raoul Verma-Führing, Dr.Contact

augenklinik@ukw.de+49 931 20120458

Locations

Where the study is run and whether each site is currently recruiting.

University Hospital WürzburgRecruiting

Würzburg, Bavaria 97080, Germany

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Wuerzburg University HospitalOTHER

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Other registered studies that closely resemble this one.

Detailed Description

Glaucoma is a progressive optic neuropathy in which elevated intraocular pressure (IOP) represents the primary modifiable risk factor. Ab-interno trabeculotomy (AIT) with the Trabectome is a minimally invasive glaucoma surgery (MIGS) that reduces IOP by ablating the trabecular meshwork and inner wall of Schlemm's canal, thereby improving aqueous humor outflow.

Previous studies have demonstrated favorable short-term IOP reduction and a good safety profile. However, robust long-term data evaluating sustained surgical success, disease progression, and the need for additional interventions over multiple years are currently lacking.

This single-center, observational study with a retrospective pre-operative baseline and a prospective cross-sectional follow-up visit addresses this knowledge gap. Patients who underwent AIT at the Department of Ophthalmology, University Hospital Würzburg, are contacted and invited for a single study visit of approximately 30 minutes.

At this visit, the following assessments are performed:

Medical history review since the time of surgery
Visual acuity assessment
Goldmann applanation tonometry (IOP measurement)
Slit-lamp biomicroscopy including gonioscopy for the anterior chamber angle
Optical coherence tomography (OCT) of the optic nerve head and retinal nerve fiber layer (RNFL)

All examinations are non-invasive, painless, and consistent with routine ophthalmic care. No additional follow-up visits are required beyond this single study contact.

Pre-operative data, including baseline IOP, glaucoma diagnosis, medication use, and surgical details are obtained from existing medical records. These are compared with findings at the study visit to evaluate long-term treatment success.

The study is initiated and funded by the Department of Ophthalmology, University Hospital Würzburg. No external funding or industry sponsorship is involved. The study has been approved by the responsible Ethics Committee with no objections raised.

Approximately 180 participants are planned for enrollment. Data are pseudonymized and stored on password-protected servers. No data transfer to third parties or outside the European Union is performed. Data will be deleted no later than 10 years after study completion.