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

Primary Purpose

Open-Angle Glaucoma, Surgery

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Goniocurettage
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open-Angle Glaucoma focused on measuring ab-interno trabeculectomy,, intraocular pressure,, open angle glaucoma, trabeculectomy, Goniocurettage, Non-Filtering Surgery

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federal University of Minas Gerais

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Eye Surgery

Arm Description

Goniocurettage was used to treat open angle glaucoma patients

Outcomes

Primary Outcome Measures

Intra Ocular Pressure
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
Central corneal endothelial cell density
Best correct visual acuity

Full Information

First Posted
October 14, 2011
Last Updated
January 17, 2012
Sponsor
Federal University of Minas Gerais
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1. Study Identification

Unique Protocol Identification Number
NCT01511094
Brief Title
Goniocurettage as First Choice of Surgical Treatment in Chronic Open-Angle Glaucoma: Outcomes and Complications
Acronym
GC
Official Title
Goniocurettage as First Choice of Surgical Treatment in Chronic Open-Angle Glaucoma: Outcomes and Complications
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
January 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-Angle Glaucoma, Surgery
Keywords
ab-interno trabeculectomy,, intraocular pressure,, open angle glaucoma, trabeculectomy, Goniocurettage, Non-Filtering Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eye Surgery
Arm Type
Experimental
Arm Description
Goniocurettage was used to treat open angle glaucoma patients
Intervention Type
Procedure
Intervention Name(s)
Goniocurettage
Other Intervention Name(s)
Ab interno glaucoma precedure, Open angle glacuoma surgery, Non filtering glaucoma procedure
Intervention Description
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 Outcome Measure Information:
Title
Intra Ocular Pressure
Description
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).
Time Frame
Change from Baseline in Intra Ocular Pressure at 20 months
Secondary Outcome Measure Information:
Title
Central Corneal Thickness
Time Frame
Two weeks before, six months after and one year after intervention
Title
Central corneal endothelial cell density
Time Frame
Two weeks before, six months after intervention and one year after intervention
Title
Best correct visual acuity
Time Frame
Two weeks before, six months after and one year after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiago T Souza, MD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sebastiao Cronemberger, PhD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Study Director
Facility Information:
Facility Name
Federal University of Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-100
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
9215060
Citation
Jacobi PC, Dietlein TS, Krieglstein GK. Technique of goniocurettage: a potential treatment for advanced chronic open angle glaucoma. Br J Ophthalmol. 1997 Apr;81(4):302-7. doi: 10.1136/bjo.81.4.302.
Results Reference
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PubMed Identifier
10334341
Citation
Jacobi PC, Dietlein TS, Krieglstein GK. Goniocurettage for removing trabecular meshwork: clinical results of a new surgical technique in advanced chronic open-angle glaucoma. Am J Ophthalmol. 1999 May;127(5):505-10. doi: 10.1016/s0002-9394(98)00448-6.
Results Reference
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PubMed Identifier
10080211
Citation
Jacobi PC, Dietlein TS, Krieglstein GK. Microendoscopic trabecular surgery in glaucoma management. Ophthalmology. 1999 Mar;106(3):538-44. doi: 10.1016/S0161-6420(99)90113-6.
Results Reference
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PubMed Identifier
11219641
Citation
Johnson DH, Johnson M. How does nonpenetrating glaucoma surgery work? Aqueous outflow resistance and glaucoma surgery. J Glaucoma. 2001 Feb;10(1):55-67. doi: 10.1097/00061198-200102000-00011.
Results Reference
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PubMed Identifier
17471324
Citation
Minckler D, Baerveldt G, Ramirez MA, Mosaed S, Wilson R, Shaarawy T, Zack B, Dustin L, Francis B. Clinical results with the Trabectome, a novel surgical device for treatment of open-angle glaucoma. Trans Am Ophthalmol Soc. 2006;104:40-50.
Results Reference
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Goniocurettage as First Choice of Surgical Treatment in Chronic Open-Angle Glaucoma: Outcomes and Complications

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