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

NCT07780916 | Recruiting DMC

• 1 other identifier: 2025-330-dvha
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

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

Keywords

Ab-interno trabeculotomy; Trabectome; Minimally invasive glaucoma surgery; MIGS; Intraocular pressure; Long-term outcomes; Trabecular meshwork; Glaucoma surgery

Outcome Measures

Primary Outcomes (1)

• Change in Intraocular Pressure (IOP) from Pre-operative Baseline to Follow-up

  Mean intraocular pressure (mmHg) measured by Goldmann applanation tonometry at the study visit, compared to pre-operative baseline IOP obtained from medical records. Surgical success is defined as IOP reduction of ≥20% from baseline and/or IOP ≤18 mmHg, with or without anti-glaucomatous medication.

  From pre-operative baseline to single follow-up visit (minimum 4 years, up to 10 years post-surgery)

Secondary Outcomes (4)

• Change in Number of Intraocular Pressure-Lowering Medications from Pre-operative Baseline to Follow-up

  From pre-operative baseline to single follow-up visit (minimum 4 years, up to 10 years post-surgery)

• Visual Acuity at Follow-up

  At single follow-up visit (minimum 4 years, up to 10 years post-surgery)

• Peripapillary Retinal Nerve Fiber Layer (RNFL) Thickness as Measured by Optical Coherence Tomography (OCT)

  At single follow-up visit (minimum 4 years, up to 10 years post-surgery)

• Rate of Surgical Failure Requiring Additional IOP-Lowering Intervention After Ab-Interno Trabeculotomy

  From date of surgery to single follow-up visit (minimum 4 years, up to 10 years post-surgery)

Study Arms (1)

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.

Procedure: Ab-interno trabeculotomy

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.

Also known as: AIT, Trabectome

AIT Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with glaucoma who underwent ab-interno trabeculotomy (AIT) using the Trabectome device at the Department of Ophthalmology, University Hospital Würzburg, between 2019 and 2021. Patients were identified retrospectively through surgical records and invited for a single prospective follow-up visit in order of longest time elapsed since surgery, prioritizing those operated earliest within the inclusion period.

You may qualify if:

• 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

You may not qualify if:

• Inability to attend the study visit
• Withdrawal of informed consent
• Insufficient medical records for pre-operative baseline data retrieval

Sponsors & Collaborators

• Wuerzburg University Hospital: lead

Study Sites (1)

University Hospital Würzburg

Würzburg, Bavaria, 97080, Germany

RECRUITING

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Raoul Verma-Führing, Dr.

  Wuerzburg University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raoul Verma-Führing, Dr.

CONTACT

+49 931 20120458; augenklinik@ukw.de

Eric Schreiner

CONTACT

ericschreiner03studium@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 24, 2026
• Study Start: December 3, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 25, 2026

Record last verified: 2026-08

Locations

DE (1)