Health TrialsbyHealthPanel

Trabeculopuncture as Predictive Test for the Success of Ab Interno Trabeculectomy

ConditionsOpen Angle GlaucomaPseudoexfoliation Glaucoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWuerzburg University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Trabeculopuncture

    Diagnostic test

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

Treatment groups

55 Participants
are divided into 1 treatment group
Group A: TrabeculopunctureExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

IOP

Intraocular pressure measured by Goldmann applanation tonometry

Time frame
before and two hours after trabeculopuncture, one and four weeks postoperatively (after ab interno trabeculectomy), and three months postoperatively
2

Outflow facility

Outflow facility is measured by the use of a pneumatonometer

Time frame
before and two hours after trabeculopuncture, one and four weeks postoperatively (after ab interno trabeculectomy), and three months postoperatively
3

Surgical success

surgical success at month three is defined as 20% IOP reduction without increasing the number of glaucoma drops

Time frame
at month three

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wuerzburg University Hospital

Lead sponsor

Source ClinicalTrials.gov
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