Goniocurettage as First Choice of Surgical Treatment in Chronic Open-Angle Glaucoma: Outcomes and Complications (GC)
Recruitment status was Active, not recruiting
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Goniocurettage as First Choice of Surgical Treatment in Chronic Open-Angle Glaucoma: Outcomes and Complications|
- Intra Ocular Pressure [ Time Frame: Change from Baseline in Intra Ocular Pressure at 20 months ] [ Designated as safety issue: Yes ]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).
- Central Corneal Thickness [ Time Frame: Two weeks before, six months after and one year after intervention ] [ Designated as safety issue: Yes ]
- Central corneal endothelial cell density [ Time Frame: Two weeks before, six months after intervention and one year after intervention ] [ Designated as safety issue: Yes ]
- Best correct visual acuity [ Time Frame: Two weeks before, six months after and one year after intervention ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2009|
|Estimated Study Completion Date:||January 2012|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Experimental: Eye Surgery
Goniocurettage was used to treat open angle glaucoma patients
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01511094
|Federal University of Minas Gerais|
|Belo Horizonte, Minas Gerais, Brazil, 30130-100|
|Principal Investigator:||Tiago T Souza, MD||Federal University of Minas Gerais|
|Study Director:||Sebastiao Cronemberger, PhD||Federal University of Minas Gerais|