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Trabeculopuncture as Predictive Test for the Success of Ab Interno Trabeculectomy

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06523751
Enrollment
55
Registered
2024-07-26
Start date
2023-06-13
Completion date
2026-01-31
Last updated
2025-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open Angle Glaucoma, Pseudoexfoliation Glaucoma

Keywords

Ab Interno Trabeculectomy, Trabeculopuncture, Open Angle Glaucoma

Brief summary

The purpose of this study is to perform trabeculopuncture a test to determine the distal outflow tract function to predict the success of ab interno trabeculectomy.

Detailed description

The aim of this study is to develop a non-invasive predictive test for the function of the distal outflow tract after ab interno trabeculectomy for open angle glaucoma. We hypothesize that the ocular pressure drop and outflow change after preoperative trabeculectomy may predict the success of ab interno trabeculectomy. The results of this study should allow trabeculopuncture to be used to select the most appropriate procedure for the individual patient.

Interventions

DIAGNOSTIC_TESTTrabeculopuncture

Trabeculopuncture is performed with a Nd:YAG laser on the trabecular meshwork. Four punctures are created along the 180° nasal trabecular meshwork.

Sponsors

Wuerzburg University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
IOPbefore and two hours after trabeculopuncture, one and four weeks postoperatively (after ab interno trabeculectomy), and three months postoperativelyIntraocular pressure measured by Goldmann applanation tonometry
Outflow facilitybefore and two hours after trabeculopuncture, one and four weeks postoperatively (after ab interno trabeculectomy), and three months postoperativelyOutflow facility is measured by the use of a pneumatonometer
Surgical successat month threesurgical success at month three is defined as 20% IOP reduction without increasing the number of glaucoma drops

Countries

Germany

Contacts

Primary ContactRaoul Verma-Fuehring, MD
vermafuehr_R@ukw.de+49 93120120662

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026