Clinical trial NCT01511094: Goniocurettage as First Choice of Surgical Treatment in Chronic Open-Angle Glaucoma: Outcomes and Complications
Official title: Goniocurettage as First Choice of Surgical Treatment in Chronic Open-Angle Glaucoma: Outcomes and Complications
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Open-Angle Glaucoma
Surgery
Keywords: ab-interno trabeculectomy,
intraocular pressure,
open angle glaucoma
trabeculectomy
Goniocurettage
Non-Filtering Surgery
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2012-01-18
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Intra Ocular Pressure
timeFrame: Change from Baseline in Intra Ocular Pressure at 20 months
Secondary outcomes:
measure: Central Corneal Thickness
timeFrame: Two weeks before, six months after and one year after intervention
measure: Central corneal endothelial cell density
timeFrame: Two weeks before, six months after intervention and one year after intervention
measure: Best correct visual acuity
timeFrame: Two weeks before, six months after and one year after intervention
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Federal University of Minas Gerais
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Tiago T Souza, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Minas Gerais
name: Sebastiao Cronemberger, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.