An observational study in Glaucoma, Glaucoma Patient and GLAUCOMA 1, OPEN ANGLE, D (Disorder), sponsored by Wuerzburg University Hospital. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Wuerzburg University Hospital · Observational
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.
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:
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.
1,419 studies on the registry are indexed under Glaucoma; 223 are open to participants now.
This study's planned enrollment of 200 is above the median of 101 across 385 observational studies indexed under Glaucoma.
Browse Glaucoma studies →Wuerzburg University Hospital is the lead sponsor of 98 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Time frame: 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
Total number of topical and systemic anti-glaucomatous medications used by the patient at the time of the study visit, compared to the number documented in medical records prior to surgery. Reduction in medication burden is considered an additional indicator of surgical success.
Time frame: From pre-operative baseline to single follow-up visit (minimum 4 years, up to 10 years post-surgery)
Visual Acuity at Follow-up
Visual acuity assessed using standardized visual acuity charts at the study visit. Results are recorded in decimal notation and converted to logMAR for analysis. Pre-operative VA is obtained from medical records for comparison.
Time frame: 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)
Peripapillary RNFL thickness (µm) assessed by spectral- domain optical coherence tomography (SD-OCT) at the study visit. Global and sectoral RNFL values are recorded. Results are compared to pre-operative OCT data from medical records where available, to evaluate structural progression of glaucomatous optic neuropathy.
Time frame: 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
Proportion of patients who required additional surgical or laser intervention (e.g., trabeculectomy, tube shunt implantation, selective laser trabeculoplasty) due to insufficient IOP control following AIT. Data obtained retrospectively from medical records. Surgical failure is defined as the need for re-intervention at any time point after the primary procedure.
Time frame: From date of surgery to single follow-up visit (minimum 4 years, up to 10 years post-surgery)
Plan to share: Undecided
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Nov 2026, 10 months after the start.
Of 110 non-industry observational studies under Glaucoma, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 208. This study's planned 10 months is below that.
Counting every sponsor, half of 134 studies reached it within 31 months; a quarter within 12 and three quarters within 208.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Wuerzburg University Hospital