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

NCT ID: NCT01511094

Last Updated: 2012-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-01-31

Brief Summary

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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

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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.

Conditions

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Open-Angle Glaucoma Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Eye Surgery

Goniocurettage was used to treat open angle glaucoma patients

Group Type EXPERIMENTAL

Goniocurettage

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Other Intervention Names

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Ab interno glaucoma precedure Open angle glacuoma surgery Non filtering glaucoma procedure

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Minas Gerais

OTHER

Sponsor Role lead

Responsible Party

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Tiago Tomaz de Souza

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tiago T Souza, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Minas Gerais

Sebastiao Cronemberger, PhD

Role: STUDY_DIRECTOR

Federal University of Minas Gerais

Locations

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Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 9215060 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10334341 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10080211 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11219641 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17471324 (View on PubMed)

Other Identifiers

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Gonio-32

Identifier Type: -

Identifier Source: org_study_id

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