Intrastromal Corneal Ring Was Effective for the Treatment of Mild Keratoconus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 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.
研究组 & 干预措施
Mild Keratoconus
A group of 65 patients with keratoconus who were implanted with an intrastromal corneal ring; the group was composed of 40 males (61.50%) and 25 females (38.50%), with a mean age of 27.88 ± 7.38 years (range, 17-47 years). The patients were fully informed about the study and signed a consent form previously approved by the ethics committee of our institution.
We used the Amsler-Krumeich classification and included only patients classified as grade I or II. The investigators performed the intraestromal corneal ring surgery in the selected group.
干预措施: Intraestromal corneal ring (Device)
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