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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
University Hospital Würzburg
RECRUITING
Würzburg
Contact Information
Primary
Raoul Verma-Führing, Dr.
augenklinik@ukw.de
+49 931 20120458
Backup
Eric Schreiner
ericschreiner03studium@gmail.com
Time Frame
Start Date: 2025-12-03
Estimated Completion Date: 2027-02-01
Participants
Target number of participants: 200
Treatments
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.
Sponsors
Leads: Wuerzburg University Hospital

This content was sourced from clinicaltrials.gov

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