Randomized Clinical Trial Investigating the Longterm Results of Early vs. Delayed Surgery for Epiretinal Fibrosis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Change in best corrected visual acuity, 12 months after enrollment
研究概览
简要总结
The goal of this randomized clinical trial is to investigate when it is optimal to treat the eye disease epiretinal fibrosis.
Hypothesis: In a population of patients with symptomatic idiopathic epiretinal fibrosis and visual acuity above 0.4, the best long term outcome measured by visual acuity is achieved by early surgery compared to periodic controls until a continual loss of visual acuity has been ensure followed by surgery.
详细描述
Epiretinal fibrosis is a disease of the macula, which affects the central retina, and there by the central vision. Epiretinal fibrosis is due to a growth of connective tissue on retinas surface.
From population studies shows that 15% of patients with epiretinal fibrosis will develop moderate to severe loss of visual acuity. Earlier studies have shown that surgery to remove the epiretinal membrane most often leads to improvements in visual acuity if not a normalization of this. The reason why not everyone has normalization of their visual acuity could be growth of connective in the deeper layers of the retina. This intraretinal fibrosis develops over time and is presumed to worsen with the duration of the condition.
In a patient with symptomatic epiretinal fibrosis and visual acuity over 0,4, the current clinical practice is to utilize the wait and see approach, where you hold of treatment until you have made sure that the patients visual acuity is declining. With the wait and see approach you avoid doing surgery on eyes that would have remained stable in their visual acuity. On the other hand will the same approach always ensure that we do surgery on eye that have deteriorated visual acuity, usually to a point of 0,1-0,3 and longer duration of disease.
Hence the results of delayed surgery are presumably worse than what could have been achieved by operating at an earlier point.
This project aims to investigate if you can give the patients a more favorable long term result by doing surgery earlier compared to the traditional wait and see approach.
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
- None
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
- •Subjective loss of visual acuity and/or visual distortions
- •Visual acuity more than or equal to 35 ETDRS letters (at 4 meter)
- •Duration of symptoms Less than 13 months
- •Metamorphopsia on a Amsler Grid
- •Binocular vision disturbed
排除标准
- •Diabetic eye symptoms
- •Previous oculary surgery, except cataract
- •Presence of hard drusen in age-related macular degeneration (AMD)
- •Other serious eye diseases
- •Patients unable to complete the follow up
- •not legal guardian of themselves
结局指标
主要结局
Change in best corrected visual acuity, 12 months after enrollment
时间窗: 12 months after enrollment
次要结局
- Retinal morphology in the control cohort, 12 months after enrollment(12 months after enrollement)
- Change in subjective quality of life 12 month after enrollment.(12 months after enrollment)
- Changes in visual field 12 months after enrollment(12 months after enrollment)
研究者
Mads Kofod
Md
Glostrup University Hospital, Copenhagen
