Study of Surgical Methods for Keratoconus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Best corrected visual acuity
研究概览
简要总结
The purpose of this study is to determine which surgical method makes less corneal haze
详细描述
Keratoconus is an asymmetric, bilateral, progressive non-inflammatory ectasia of the cornea. The investigators evaluate whether partial removal versus total removal of the corneal epithelium can lead to less corneal haze and better visual outcomes.
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
- 16 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 16-40 years
- •axial topography consistent with keratoconus
- •minimum corneal thickness more than 400 µm and a progression of keratoconus in past 12 months
排除标准
- •history of ocular herpes or non-healing corneal ulcers
- •subjects with current ocular infection
- •severe preoperative corneal haze or scar
- •severe ocular surface disease
- •autoimmune diseases
- •pregnant women
研究组 & 干预措施
total removal
patients underwent Corneal collagen cross-linking procedure with totally corneal epithelium removing. Total removal was performed by mechanical debridement of the corneal epithelium over the central 9 mm.
干预措施: collagen cross-linking procedure (total removal) (Procedure)
partial removal
patients underwent Corneal collagen cross-linking procedure with partially corneal epithelium removing. Partial removal was performed by removing a 3-mm width ring and leaving the central 3 mm of the cornea intact.
干预措施: collagen cross-linking procedure (partial removal) (Procedure)
结局指标
主要结局
Best corrected visual acuity
时间窗: at six months after surgery
determining corrected visual acuity in partial removal versus total removal of the corneal epithelium
次要结局
- Corneal optical density(at six months after surgery)
研究者
Hamidreza Shemshaki
MD, Research Assistant
Isfahan University of Medical Sciences