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

• Sponsor: Federal University of Minas Gerais (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01511094
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arm: 1
• Duration (Months): 31
• Patients Per Site Per Month: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Open-Angle Glaucoma; Surgery	Procedure: Goniocurettage	Phase 2/Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: N/A
• 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
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: May 1, 2010
• Anticipated Study Completion Date: Jan 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Intra Ocular Pressure [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

1. Central Corneal Thickness [Two weeks before, six months after and one year after intervention]

2. Central corneal endothelial cell density [Two weeks before, six months after intervention and one year after intervention]

3. Best correct visual acuity [Two weeks before, six months after and one year after intervention]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• Jacobi PC, Dietlein TS, Krieglstein GK. Microendoscopic trabecular surgery in glaucoma management. Ophthalmology. 1999 Mar;106(3):538-44.
• 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.
• Johnson DH, Johnson M. How does nonpenetrating glaucoma surgery work? Aqueous outflow resistance and glaucoma surgery. J Glaucoma. 2001 Feb;10(1):55-67. Review.
• 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.

• Responsible Party: Tiago Tomaz de Souza, Principal Investigator, Federal University of Minas Gerais
• ClinicalTrials.gov Identifier: NCT01511094
• Other Study ID Numbers: Gonio-32
• First Posted: Jan 18, 2012
• Last Update Posted: Jan 18, 2012
• Last Verified: Jan 1, 2012

• Keywords provided by Tiago Tomaz de Souza, Principal Investigator, 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

Study Results

No Results Posted as of Jan 18, 2012