Goniocurettage as First Choice of Surgical Treatment in Chronic Open-Angle Glaucoma: Outcomes and Complications

Study Overview
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Brief Summary
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The study has the purpose to evaluate the effectiveness and safety of the goniocurettage as a first choice of surgical treatment for primary open-angle glaucoma (POAG) in patients with good vision.

Detailed Description
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A prospective study in 33 eyes (32 patients) with uncontrolled open angle glaucoma under clinical treatment. The trabecular tissue was scraped away from the angle (goniocurettage) in about 100 degrees by means of an instrument similar to a microchalazion curette. The goniocurettage was done under direct visualization of the angle through a gonioscopy lens (Swan-Jacob) and a surgical microscope. Using the 17.0 SPSS software the investigators compared the intraocular pressure, the numbers of antiglaucomatous medications, the best correct visual acuity, the development of cataract, the central corneal thickness,the impact on the visual field, the impact on the optic nerve head and the central corneal endothelial cell density before and after the goniocurettage, and the intra and post operative complications.

Official Title
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Goniocurettage as First Choice of Surgical Treatment in Chronic Open-Angle Glaucoma: Outcomes and Complications

Conditions
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Open-Angle Glaucoma, Surgery

Intervention / Treatment
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* Procedure: Goniocurettage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Disc and/or visual field findings consistent with Primary Open Angle Glaucoma Uncontrolled intraocular pressure (≥21 mm Hg) or progressive glaucomatous neuropathy despite maximum tolerated medical therapy 40 years old or over Visual acuity higher than 0.2 Open angles (greater or equal to Shaffer grade II) Exclusion Criteria: Previous ocular surgery History of glaucoma laser treatment History of ocular trauma Cyclodestructive procedures Corneal edema or opacities Endothelial decompensation History of uveitis Secondary glaucoma neovascularization of the iris or angle Congenital anterior segment abnormalities Anatomically confusing angles without clear definition of the scleral spur or meshwork and inability to maintain follow-up

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eye Surgery<br>Goniocurettage was used to treat open angle glaucoma patients | Procedure: Goniocurettage<br>* Ab interno surgery consisting on scraped away the trabecular tissue from the angle (goniocurettage) removing segments of pathologically altered trabecular meshwork from the scleral sulcus<br>* Other names: Non filtering glaucoma procedure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra Ocular Pressure | The mean of at least three measures at 8:00 am two weeks before surgery. After intervention, the Intra Ocular Pressure was measured on the day after, one week after, two weeks after and every month at the same time until the end of the study (an expected average of 20 months). | Change from Baseline in Intra Ocular Pressure at 20 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Corneal Thickness |  | Two weeks before, six months after and one year after intervention | 
| Central corneal endothelial cell density |  | Two weeks before, six months after intervention and one year after intervention | 
| Best correct visual acuity |  | Two weeks before, six months after and one year after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ab-interno trabeculectomy,, intraocular pressure,, open angle glaucoma, trabeculectomy, Goniocurettage, Non-Filtering Surgery