Open Angle Glaucoma, Pseudoexfoliation Glaucoma
Conditions
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
Trabeculopuncture is performed with a Nd:YAG laser on the trabecular meshwork. Four punctures are created along the 180° nasal trabecular meshwork.
Sponsors
Study design
Intervention model description
Determining Distal Outflow Tract Function in Open Angle Glaucoma as a Predictive Test for the Success of Ab Interno Trabeculectomy
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| IOP | before and two hours after trabeculopuncture, one and four weeks postoperatively (after ab interno trabeculectomy), and three months postoperatively | Intraocular pressure measured by Goldmann applanation tonometry |
| Outflow facility | before and two hours after trabeculopuncture, one and four weeks postoperatively (after ab interno trabeculectomy), and three months postoperatively | Outflow facility is measured by the use of a pneumatonometer |
| Surgical success | at month three | surgical success at month three is defined as 20% IOP reduction without increasing the number of glaucoma drops |
Countries
Germany