A Multicenter Trial for Surgical Treatment of Central Retinal Vein Occlusion - Radial Optic Neurotomy for CVO The ROVO Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 2
- 主要终点
- Proportion of eyes with an improvement of more than 15 letters (approximately > 3 lines of visual acuity gain) after one year as compared to baseline
研究概览
简要总结
The ROVO study is a prospective, placebocontrolled and randomised study designed to evaluate the effect of radial optic neurotomy in central vein occlusion, versus triamcinolone acetonide. 240 patients with a visual acuity < 0.5 Snellen will be randomised. Patients are treated with either RON, or a single intravitreal injection of 4 mg triamcinolone acetonide, or a placebo treatment - a "sham" injection of intravitreal triamcinolone. Patients will be examined regularly over a period of one year.
Best corrected visual acuity for far and near, as well as clinical examinations, fluorescein- and indocyanine green angiograms, optical coherence tomography, and perimetry, are performed pre- and postoperatively.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Onset of CVO not longer than 12 months
- •nonperfused - (greater than 10 disc area of nonperfusion)
- •perfused - visual acuity lower than 0.1 Snellen,or
- •perfused with no improvement of visual acuity over 4 weeks)
排除标准
- •• Dense cataract* (grade 3 and 4) which precludes judgement of the fundus.
- •Pregnancy
- •Allergy against Fluoresceine or Indocyanine green
- •Unable to come for follow up visit
- •Presence of other severe retinopathy or
- •Presence of advanced optic atrophy or uncontrolled glaucoma.
- •Visual acuity higher than 0.5 Snellen.
结局指标
主要结局
Proportion of eyes with an improvement of more than 15 letters (approximately > 3 lines of visual acuity gain) after one year as compared to baseline
次要结局
未报告次要终点