Randomized Trial of Laser Ablation for Highly Symptomatic Floaters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- Efficacy of the laser treatment measured by the improvement of visual acuity and floater specific Visual Function Questionnaire (VFQ).
研究概览
简要总结
Vitreous floaters are tiny, cloudy, clumps of cells that appear in the otherwise clear fluid (vitreous) that fills the back 3/4 of the eye. Floaters are commonly caused by eye conditions such as posterior vitreous detachment (PVD), vitreous syneresis and asteroid hyalosis. While these symptoms are considered physiological in nature, they can be of considerable inconvenience to many patients which affect essential activities. The investigators wish to assess the safety and efficacy of floater treatment in patients with highly symptomatic floaters using an FDA approved nanosecond infrared yttrium aluminum garnet (YAG) lasers.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have been diagnosed with symptomatic floaters lasting more than 2 months
- •Willing to proceed with intervention
- •Be able to provide informed consent
- •Diagnosed with Posterior Vitreous Detachment
- •Accept a 1% risk of complications
排除标准
- •Less than 19 years of age
- •Is a high myope (greater than -6 diopters)
- •Has monocular vision
- •Diagnosed with asteroid hyalosis
- •Diagnosed with acute on-set of floaters (less than two months and may clear spontaneously)
- •Has corneal or lenticular opacities or any media opacity which may interfere with treatment
- •Has any concomitant ocular disease or pathology
- •Has elevated intraocular pressure (IOP) or on IOP lowering medication
- •Has floaters that are deemed to require more than five treatment sessions, where surgical intervention is the best treatment course
- •Has floaters inaccessible with current lasers and lenses
- •Has floaters located less than 2mm from the crystalline lens or the retina
- •Found to have retinal tears or retinal detachment on initial examination or has had a history of retinal detachment repair within the last two years
- •Has psychiatric problems that may recur or worsen
- •Incapacity to provide informed consent
结局指标
主要结局
Efficacy of the laser treatment measured by the improvement of visual acuity and floater specific Visual Function Questionnaire (VFQ).
时间窗: after the last treatment session (approximately 5 days)
次要结局
- Number of complications in the laser treated eyes compared to the non-treated eyes(6 months)