NCT07780916|RecruitingDMC
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Sponsor study identifier
observational
200
1 country
1
Study Start
December 3, 2025
Actual (reported)Primary Completion
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 3, 2025
Actual (reported)August 18, 2026
Actual (reported)August 24, 2026
Actual (reported)November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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)
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
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
University Hospital Würzburg
Würzburg, Bavaria, 97080, Germany
Raoul Verma-Führing, Dr.
Wuerzburg University Hospital
First Submitted
August 18, 2026
First Posted
August 24, 2026
Study Start
December 3, 2025
Actual (reported)Primary Completion
November 1, 2026
EstimatedTranscorneal Electrical Stimulation for the Treatment of Visual Field Defects in Patients With Open-Angle Glaucoma
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)
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 25, 2026
Record last verified: 2026-08
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Source: ClinicalTrials.gov.
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