Fresh Corneal Lenticule Implantation in Hyperopic Patients With High Astigmatism
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Increase of visual acuity, accommodation process
研究概览
简要总结
The refractive combination of high hyperopia with high astigmatism is difficult to treat surgically. In addition, there are not many suitable options to offer such patients presenting with this condition. The method used at the EYE Hospital Pristina using fresh lenticule implantation by ReLex-SMILE is safe and effective method. Fresh Corneal Implantation is a safe treatment for hyperopia with high astigmatism comparing with refractive IOL implantation (loss of accommodation, endophthalmitis). Its primary objective is to increase visual acuity, accommodation process, patient satisfaction which makes patient to enjoy a happier life. We believe this study will be the future of refractive surgery for treating high hyperopia.
详细描述
This study is to investigate the effect of fresh corneal lenticule implantation as allogenic implant that will be taken from myopic patients to implant in hyperopic patients with high astigmatism using VisuMax Femtosecond laser - Smile module surgery with primary objective to assess (increase) visual acuity (far, intermediate, near vision) and secondary objective to stabilize (decrease) high astigmatism by reducing K-values.
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
盲法说明
Miopic Group Hyperopic Group
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with high spherical hyperopia over + 4.5 D
- •astigmatism over + 3 cyl.
- •corneal thickness minimum 450 µm and maximum 550 µm.
排除标准
- •corneal thickness over 550 µm
- •history of glaucoma
- •retinal detachment
- •history of ocular inflammation.
研究组 & 干预措施
FRESH CORNEAL LENTICULE IMPLANTATION
The aim of this study is to investigate the effect of fresh corneal lenticule implantation as allogenic implant that will be taken from myopic patients to implant in hyperopic patients with high astigmatism using VisuMax Femtosecond Laser-Smile module surgery with primary objective to assess(increase) visual acuity (far, intermediate, near vision) and secondary objective to stabilize(decrease) high astigmatism by reducing K values. Fresh corneal lenticule implantation as allogenic implant that we took from myopic patients (-5.0D) to implant in hyperopic patients (+4.0 D +3.0cyl) according to high K2 values. The stromal pocket diameter was 8 mm, 4mm super incision and 130-µm cap thickness.
干预措施: Fresh Corneal Lenticule Implantation using Relex-Smile VisuMax Femtosecond Laser (Device)
结局指标
主要结局
Increase of visual acuity, accommodation process
时间窗: 12 months
Using fresh myopic corneal lenticule resulted in the increase of the visual acuity (far, intermediate and near vision)
次要结局
- Decrease of high hyperopic astigmatism(12 months)
研究者
Dr. Faruk Semiz
Head of Ophthalmology Department
Eye Hospital Pristina Kosovo