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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Tiago Tomaz de Souza, Federal University of Minas Gerais
ClinicalTrials.gov Identifier:
NCT01511094
First received: October 14, 2011
Last updated: January 17, 2012
Last verified: January 2012
History of Changes
  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: 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

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by Federal University of Minas Gerais:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: October 14, 2011
Last Updated: January 17, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by 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

ClinicalTrials.gov processed this record on June 13, 2013