Treatment of Cystoid Macular Edema in Patients With Retinal Degeneration
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Number of Participants With Improvement in Macular Fluid as Measured Subjectively by Optical Coherence Tomography (OCT)
研究概览
简要总结
A small percentage of patients with retinal degeneration accumulate fluid in the center of their retina.
Previous studies using an oral form of treatment has been successful in decreasing this fluid which improves vision.
This study will test the use of a topically applied form of this treatment to the eye to reduce the amount of fluid and improve or preserve vision.
详细描述
Patients with certain retinal degenerations will be asked to take part in a research study about the use of a topically applied eye drop for treating fluid in the central part of the retina (macular edema).
In the current study, investigators propose to use topical Trusopt in a group of patients with retinal degeneration (RD) to determine its effectiveness in reducing the amount of retinal fluid in patients with RD and macular edema. The methods will involve an initial one month treatment with topical Trusopt three times a day in each eye. After a period of one month, patients will return for a follow-up examination. At baseline, they will have had a measurement of their center vision and a measurement of their macular fluid with a photographic-like procedure termed optical coherence tomography (OCT). After the one month period of treatment, they will again have a measurement of their vision and re-evaluation with OCT. An improvement at least of one line (7 letters) or more of vision will be considered as a clinically significant improvement.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of cystic macular fluid on OCT testing
排除标准
- •Allergic reaction to sulpha containing compounds
- •Intolerance to dorzolamide (Trusopt)
研究组 & 干预措施
Trusopt (2% dorzolamide)
Intent to treat population. All participants assigned to Trusopt (2% dorzolamide)
干预措施: 2% dorzolamide (Drug)
结局指标
主要结局
Number of Participants With Improvement in Macular Fluid as Measured Subjectively by Optical Coherence Tomography (OCT)
时间窗: Baseline and most recent visit (2 months up to 36 months)
Macular fluid measured subjectively by OCT. A 25% or greater reduction of macular fluid was considered an improvement. While initially it was our intent to follow participants at 1, 4, and 7 month intervals, these time periods could not be consistently adhered to based on participant non-compliance with appointments. Consequently, additional participants were subsequently seen at baseline to various time points beyond seven months that ranged from 2 months to 36 months at their most recent visit.
Number of Participant With Improvement in Foveal Thickness (Macular Fluid) as Measured by Optical Coherence Tomography (OCT)
时间窗: Baseline and most recent visit (2 month up to 36 months)
Foveal thickness measured by OCT. A 17% or greater reduction in foveal thickness was considered an improvement. While initially it was our intent to follow participants at 1, 4, and 7 month intervals, these time periods could not be consistently adhered to based on participant non-compliance with appointments. Consequently, additional participants were subsequently seen at baseline to various time points beyond seven months that ranged from 2 months to 36 months at their most recent visit.
次要结局
- Number of Participants With Improvement of Seven Letters or More Read on a Visual Chart(Baseline and most recent visit (2 months up to 36 months))
研究者
Gerald A. Fishman
Emeritus Professor of Ophthalmology
University of Illinois at Chicago