ODM 5 in the Treatment of Corneal Edematous Fuchs' Endothelial Dystrophy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 4
- 主要终点
- Visual acuity (both eyes)
研究概览
简要总结
Clinical observation to confirm the clinical safety and efficacy of ODM 5 in the treatment of corneal edema caused by Fuchs' endothelial dystrophy.
详细描述
Patients with a Fuchs' endothelial dystrophy-induced corneal edema and an ODM 5 therapy recommendation prior to their inclusion will be observed in normal practice setting in this post-market clinical follow-up study. In this indication, the use of ODM 5 should extract the fluid excess in the cornea away by an osmotic effect, enabling the cornea to temporarily regain a normal state of hydration. As a consequence, the patient's visual acuity, contrast perception, corneal thickness and ocular complaints/symptoms should improve. The hyaluronan in ODM 5 helps to protect and heal the cornea in case of irritation and thus, enables the cornea to regain a normal state of hydration and participates in improving the quality of vision.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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 corneal oedema caused by Fuchs' endothelial dystrophy
- •Existing ODM 5 recommendation prior to inclusion
排除标准
- •Contact lens wear
- •Hypersensitivity to one of the ODM 5 components
- •Appointment for eye surgery within 8 weeks after date of inclusion
结局指标
主要结局
Visual acuity (both eyes)
时间窗: Day 56
Measurement of uncorrected and best corrected visual acuity (both eyes)
次要结局
- Visual acuity (both eyes)(Day 0 and day 28)
- Corneal thickness(Day 0, day 28 and day 56)
- Contrast perception (Measurement of contrast values (both eyes))(Day 0, day 28 and day 56)
- Safety parameter (Adverse events)(Day 0, day 28 and day 56)
- Subjective ocular complaints and symptoms (11-point Likert scale)(Day 0, day 28 and day 56)