Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06523751

Determining Distal Outflow Tract Function in Open Angle Glaucoma as a Predictive Test for the Success of Ab Interno Trabeculectomy

Led by Wuerzburg University Hospital · Updated on 2025-04-03

55

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying open angle glaucoma and pseudoexfoliation glaucoma to develop a non-invasive test called trabeculopuncture. This test aims to evaluate the function of the distal outflow tract and predict how successful ab interno trabeculectomy surgery might be for patients. The study is sponsored by Wuerzburg University Hospital and seeks to personalize treatment by selecting the most suitable surgical procedure based on this predictive test. Participants will undergo trabeculopuncture using a Nd:YAG laser to create four punctures along the nasal trabecular meshwork before having ab interno trabeculectomy surgery. The study involves measuring eye pressure and outflow function before and after the laser test, as well as at multiple time points after surgery, including two hours, one week, four weeks, and three months postoperatively. During the study, participants will have intraocular pressure (IOP) and outflow facility measured at the specified time points to assess the effect of trabeculopuncture and surgery. Researchers will evaluate surgical success three months after the procedure. The study requires ongoing monitoring and testing during these periods to track eye pressure changes and the function of the eye's fluid drainage system, with total participation lasting at least three months after surgery.

CONDITIONS

Brief Title

Trabeculopuncture as Predictive Test for the Success of Ab Interno Trabeculectomy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals 18 years of age or older
  • Clinical diagnosis of primary open angle glaucoma, pigmentary glaucoma, or pseudoexfoliation glaucoma
  • Uncontrolled intraocular pressure despite maximally tolerated medical therapy
  • Progressive thinning of the retinal nerve fiber layer assessed by spectral domain optical coherence tomography (p < 0.05)
  • Progression of visual field defects
  • Presence of visually significant cataract with indication to reduce intraocular pressure or glaucoma medication burden
Not Eligible

You will not qualify if you...

  • Diagnosis of neovascular glaucoma, angle-closure glaucoma, or uveitic glaucoma
  • History of prior glaucoma surgery
  • Preexisting conditions affecting episcleral venous pressure, including Grave's ophthalmopathy, Sturge-Weber syndrome, or carotid-cavernous fistula

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Single day

Participants undergo trabeculopuncture using a Nd:YAG laser to assess the function of the distal outflow tract before ab interno trabeculectomy.

1 visit (in-person)

Treatment

Duration - Single day

Participants receive ab interno trabeculectomy as part of the treatment following diagnostic evaluation.

1 visit (in-person)

Post-operative Follow-up

Duration - 3 months

Participants are monitored after surgery with assessments of intraocular pressure and outflow facility to evaluate surgical success.

Visits at 2 hours after trabeculopuncture, and at 1 week, 4 weeks, and 3 months postoperatively

Trial Site Locations

Total: 1 location

1

Uniklinikum Würzburg

Würzburg, Bavaria, Germany, 97080

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Research Team

R

Raoul Verma-Fuehring, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Published Research Related To This Trial