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

Phase 2

• Conditions: Surgery; Open-Angle Glaucoma
• Interventions: Procedure: Goniocurettage

• Registration Number: NCT01511094
• Lead Sponsor: Federal University of Minas Gerais

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2010-05
• Study First Submitted: 2011-10-14
• Status Verified: 2012-01
• Study Completion: 2012-01
• Study First Submitted QC: 2012-01-17
• Last Update Submitted: 2012-01-17
• Study First Posted: 2012-01-18
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Eye Surgery	Goniocurettage	Goniocurettage was used to treat open angle glaucoma patients

Primary Outcome Measures

Name	Time	Method
Intra Ocular Pressure	Change from Baseline in Intra Ocular Pressure at 20 months	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).

Secondary Outcome Measures

Name	Time	Method
Best correct visual acuity	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
Central Corneal Thickness	Two weeks before, six months after and one year after intervention

Trial Locations

Locations (1)

Federal University of Minas Gerais; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil