NCT03127163已完成不适用
Intrastromal Corneal Ring Was Effective for the Treatment of Mild Keratoconus
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Aberrations were measured and the visual function was determined using clinical indices.
研究概览
简要总结
To determine whether the implantation of an intrastromal corneal ring is an effective treatment for a homogeneous group of mild keratoconus patients.
详细描述
A group of 65 patients with mild keratoconus were implanted with a Ferrara ring in a single eye. Six months after surgery, the aberrations were measured and the visual function was determined using clinical indices. The aberrations, especially comatic aberration (coma), were measured independently.
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
- 17 Years 至 47 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Investigators used the Amsler-Krumeich classification and included only patients classified as grade I or II.
排除标准
- •Investigators excluded patients with central corneal scarring, with other eye disorders, or with previous ocular surgery. We also excluded patients with a history of herpes infection, keratitis, corneal dystrophies, diagnoses of autoimmune diseases, systemic connective tissue disorders, or acute keratoconus.
结局指标
主要结局
Aberrations were measured and the visual function was determined using clinical indices.
时间窗: 3 months after surgery
Wave front data
次要结局
- UCVA(3 months after surgery)
- BCVA(3 months after surgery)
研究者
Mário Henrique Camargos de Lima
PhD
University of Sao Paulo
研究点 (2)
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