Goniocurettage as First Choice of Surgical Treatment in Chronic Open-Angle Glaucoma: Outcomes and Complications
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Intra Ocular Pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Intra Ocular Pressure
时间窗: 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).
次要结局
- Central corneal endothelial cell density(Two weeks before, six months after intervention and one year after intervention)
- Central Corneal Thickness(Two weeks before, six months after and one year after intervention)
- Best correct visual acuity(Two weeks before, six months after and one year after intervention)
研究者
Tiago Tomaz de Souza
Principal Investigator
Federal University of Minas Gerais