Predicting success of glaucoma surgery using trabeculopuncture
Determining Distal Outflow Tract Function in Open Angle Glaucoma as a Predictive Test for the Success of Ab Interno Trabeculectomy
This study is testing a new non-invasive method to see if it can help predict how well glaucoma surgery will work for patients who still have high eye pressure despite treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wuerzburg University Hospital Academic / other |
| Locations | 1 site (Würzburg, Bavaria) |
| Trial ID | NCT06523751 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a non-invasive test called trabeculopuncture to assess the function of the distal outflow tract in patients with open angle glaucoma. By measuring changes in ocular pressure and outflow before surgery, the researchers hope to predict the success of ab interno trabeculectomy. This approach could help tailor surgical interventions to individual patient needs, potentially improving outcomes. The study will involve patients who have uncontrolled intraocular pressure despite medical therapy and show signs of glaucoma progression.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with uncontrolled intraocular pressure and progressive glaucoma despite maximally tolerated medical therapy.
Not a fit: Patients with neovascular glaucoma, angle-closure glaucoma, or those who have had prior glaucoma surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment options for patients with glaucoma.
How similar studies have performed: While the approach of using trabeculopuncture is innovative, similar predictive tests for glaucoma surgery outcomes have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * individuals ≥ 18 years of age * clinical diagnosis of: primary open angle glaucoma, pigmentary glaucoma, or pseudoexfoliation glaucoma * uncontrolled intraocular pressure (IOP) with maximally tolerated medical therapy * progressive thinning of retinal nerve fiber layer assessed by Spectral domain optical coherence tomography (p \< 0.05) * progression of visual field defects * visually significant cataract and indication to reduce IOP or glaucoma medication burden Exclusion Criteria: * clinical diagnosis of neovascular glaucoma, angle-closure glaucoma, uveitic glaucoma, neovascular glaucoma * prior glaucoma surgery * preexisting conditions affecting the episcleral venous pressure including Grave's ophthalmopathy, Sturge-Weber syndrome, Arteriovenous fistulas (carotid-cavernous fistula)
Where this trial is running
Würzburg, Bavaria
- Uniklinikum Würzburg — Würzburg, Bavaria, Germany (Recruiting)
Study contacts
- Principal investigator: Daniel Kampik, MD, PhD — Department of Ophthalmology University Hospital Würzburg
- Study coordinator: Raoul Verma-Fuehring, MD
- Email: vermafuehr_R@ukw.de
- Phone: +49 93120120662
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.