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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by Tiago Tomaz de Souza, Federal University of Minas Gerais.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01511094
First Posted: January 18, 2012
Last Update Posted: January 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tiago Tomaz de Souza, Federal University of Minas Gerais
  Purpose
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.

Condition Intervention Phase
Open-Angle Glaucoma Surgery Procedure: Goniocurettage Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Goniocurettage as First Choice of Surgical Treatment in Chronic Open-Angle Glaucoma: Outcomes and Complications

Resource links provided by NLM:


Further study details as provided by Tiago Tomaz de Souza, Federal University of Minas Gerais:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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 ]

Enrollment: 32
Study Start Date: June 2009
Estimated Study Completion Date: January 2012
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511094


Locations
Brazil
Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 30130-100
Sponsors and Collaborators
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
  More Information

Publications:
Responsible Party: Tiago Tomaz de Souza, Principal Investigator, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT01511094     History of Changes
Other Study ID Numbers: Gonio-32
First Submitted: October 14, 2011
First Posted: January 18, 2012
Last Update Posted: January 18, 2012
Last Verified: January 2012

Keywords provided by Tiago Tomaz de Souza, Federal University of Minas Gerais:
ab-interno trabeculectomy,
intraocular pressure,
open angle glaucoma
trabeculectomy
Goniocurettage
Non-Filtering Surgery

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases