Corneal Lenticule Implantation in Keratoconus Disease With Relex Smile Surgery
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Increase of corneal thickness at patients Lenticule group
研究概览
简要总结
CORNEAL LENTICULE IMPLANTATION IN KERATOCONUS DISEASE WITH RELEX SMILE SURGERY
详细描述
Purpose:
The purpose of our study is to investigate the feasibility and effect of fresh lenticule implantation as allogenic graft that will be taken from myopic patients, in order to implant in patients with keratocouns disease using VisuMax Femtosecond laser - Smile module surgery which primary objective in to increase central corneal thickness and secondary objective is to improve visual acuity and reducing K-values.
Methods:
All the patients were clinically diagnosed with progressive keratoconus. Twenty (20) patients underwent SMILE surgery (first group), and twenty (20) patients underwent lenticule implantation (second group). Visual acuity, corneal topography, electron microscop,anterior segment optical coherence tomography, were analyzed.
Outcome:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients clinically diagnosed with progressive keratoconus
排除标准
- •Active anterior segment pathologic features, Corneal thickness over 420, Previous corneal or anterior segment surgery
研究组 & 干预措施
Smile Group
Twenty patients (20) underwent SMILE surgery (first group)
干预措施: Lenticule Implantation in Keratoconus Disease with RELEX Smile Surgery (Procedure)
Lenticule Group
Twenty patients (20) underwent lenticule implantation (second group)
干预措施: Lenticule Implantation in Keratoconus Disease with RELEX Smile Surgery (Procedure)
结局指标
主要结局
Increase of corneal thickness at patients Lenticule group
时间窗: 12 months
Increase of corneal central thickness using fresh lenticule with stromal stem cells and live keratocytes
次要结局
- Improvement of visual acuity at patients Lenticule group(12 months)
研究者
Dr. Faruk Semiz
Principal Doctor
Eye Hospital Pristina Kosovo