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

Surgery Clinical Trial

— GC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01511094
• Other study ID #: Gonio-32
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: October 14, 2011
• Last updated: January 17, 2012
• Start date: June 2009
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: January 2012
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Open-Angle Glaucoma
• Surgery

Intervention

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

Locations

Country	Name	City	State
Brazil	Federal University of Minas Gerais	Belo Horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

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. — View Citation

Jacobi PC, Dietlein TS, Krieglstein GK. Microendoscopic trabecular surgery in glaucoma management. Ophthalmology. 1999 Mar;106(3):538-44. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Change from Baseline in Intra Ocular Pressure at 20 months	Yes
Secondary	Central Corneal Thickness		Two weeks before, six months after and one year after intervention	Yes
Secondary	Central corneal endothelial cell density		Two weeks before, six months after intervention and one year after intervention	Yes
Secondary	Best correct visual acuity		Two weeks before, six months after and one year after intervention	Yes