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

NCT01511094 | Unknown Phase 2

• 1 other identifier: Gonio-32
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Open-Angle Glaucoma; Surgery

Keywords

ab-interno trabeculectomy,; intraocular pressure,; open angle glaucoma; trabeculectomy; Goniocurettage; Non-Filtering Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Central Corneal Thickness

  Two weeks before, six months after and one year after intervention

• Central corneal endothelial cell density

  Two weeks before, six months after intervention and one year after intervention

• Best correct visual acuity

  Two weeks before, six months after and one year after intervention

Study Arms (1)

Eye Surgery

EXPERIMENTAL

Goniocurettage was used to treat open angle glaucoma patients

Procedure: Goniocurettage

Interventions

Goniocurettage PROCEDURE

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

Also known as: Ab interno glaucoma precedure, Open angle glacuoma surgery, Non filtering glaucoma procedure

Eye Surgery

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years old or over
• Visual acuity higher than 0.2
• Open angles (greater or equal to Shaffer grade II)

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

Related Publications (5)

• 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.

  PMID: 9215060 BACKGROUND

• 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.

  PMID: 10334341 BACKGROUND

• 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.

  PMID: 10080211 BACKGROUND

• 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.

  PMID: 11219641 BACKGROUND

• 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.

  PMID: 17471324 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Tiago T Souza, MD

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

• Sebastiao Cronemberger, PhD

  Federal University of Minas Gerais

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 14, 2011
• First Posted: January 18, 2012
• Study Start: June 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: January 1, 2012
• Last Updated: January 18, 2012

Record last verified: 2012-01

Locations

BR (1)