Topical Brimonidine vs Argon Laser Trabeculoplasty in Progressing Human Glaucoma. A Prospective Randomized Clinical Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- progression of visual field measured as loss of sensitivity in decibels per year
研究概览
简要总结
This study is evaluating possible non-intraocular pressure (IOP) related effects of the alpha-1 agonist brimonidine in human subjects affected by a progressive glaucomatous optic neuropathy. Brimonidine was proven as neuroprotective in several pre-clinical animal studies.
详细描述
Patients with open angle glaucoma and a history of relative stability of the visual field are followed for 18 months. A visual field is measured every 3 months for a total number of n = 6 eligible fields at the end of this phase. Then, those eyes showing progression of the field (i.e. deterioration of th eexisting glaucoma), are randomized to receive either 0.2% brimonidine tartrate eyedrops b.i.d. or 360° argon laser trabeculoplasty in one session. Either treatment will be put "on top" of the pre-existing anti-glaucoma therapy. Then, a further 18-month phase is planned, with a sequnece of field taken at the same pace as the previous phase. Progression is detected (and measured) acording to a trend-analysis (i.e. regression vs time of single points and of clusters of adjacent points).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Glaucomatous visual field defect on achromatic perimetry (24/2 Humphrey full threshold,abnormal GHT and CPSD, p<0.01) considered clinically "unstable"
- •IOP < 20 mmHg on repeated readings with no more than 2 medications,
- •Open angle on gonioscopy,
- •Glaucomatous optic neuropathy (HRTII, Moorfields regression analysis),
- •Clear lens (LOCS2 score < C1, N0, P0)
- •Best corrected visual acuity better than 0.2 LogMAR (ETDRS chart),
- •No previous bulbar surgery
- •Manifest refraction within - 5 and + 2 diopters
- •No comorbidity (AMD and diabetic retinopathy.and negative history for neurological diseases)
排除标准
- •Closed angle
- •Previous bulbar surgery
- •Unstable IOP
- •Unreliable visual fields on historic data
结局指标
主要结局
progression of visual field measured as loss of sensitivity in decibels per year
progression of visual field measured as number of eyes showing at least one cluster of points progressing
次要结局
- number of drop out(s) for adverse events