Overview

This trial is active, not recruiting.

Conditions open-angle glaucoma, surgery
Treatment goniocurettage
Phase phase 2/phase 3
Sponsor Federal University of Minas Gerais
Start date June 2009
End date May 2010
Trial size 32 participants
Trial identifier NCT01511094, Gonio-32

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Goniocurettage was used to treat open angle glaucoma patients
goniocurettage Ab interno glaucoma precedure
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

Primary Outcomes

Measure
Intra Ocular Pressure
time frame: Change from Baseline in Intra Ocular Pressure at 20 months

Secondary Outcomes

Measure
Central Corneal Thickness
time frame: Two weeks before, six months after and one year after intervention
Central corneal endothelial cell density
time frame: Two weeks before, six months after intervention and one year after intervention
Best correct visual acuity
time frame: Two weeks before, six months after and one year after intervention

Eligibility Criteria

Male or female participants at least 40 years old.

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

Additional Information

Official title Goniocurettage as First Choice of Surgical Treatment in Chronic Open-Angle Glaucoma: Outcomes and Complications
Principal investigator Tiago T Souza, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2012.
Information provided to ClinicalTrials.gov by Federal University of Minas Gerais.