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

January 17, 2012 updated by: Tiago Tomaz de Souza, Federal University of Minas Gerais
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130-100
        • Federal University of Minas Gerais

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eye Surgery
Goniocurettage was used to treat open angle glaucoma patients
Procedure: Goniocurettage
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
Other Names:
  • Ab interno glaucoma precedure
  • Open angle glacuoma surgery
  • Non filtering glaucoma procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra Ocular Pressure
Time Frame: 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).
Change from Baseline in Intra Ocular Pressure at 20 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Central Corneal Thickness
Time Frame: Two weeks before, six months after and one year after intervention
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
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
Two weeks before, six months after and one year after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Minas Gerais

Investigators

  • Principal Investigator: Tiago T Souza, MD, Federal University of Minas Gerais
  • Study Director: Sebastiao Cronemberger, PhD, Federal University of Minas Gerais

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

October 14, 2011

First Submitted That Met QC Criteria

January 17, 2012

First Posted (Estimate)

January 18, 2012

Study Record Updates

Last Update Posted (Estimate)

January 18, 2012

Last Update Submitted That Met QC Criteria

January 17, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gonio-32

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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