NCT03805425Unknown不适用
Photorefractive Intrastromal Corneal Crosslinking (PiXL) for Correction of Hyperopia
Gemini Eye Clinic2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2016年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in Subjective Refraction
研究概览
简要总结
This clinical study aims to investigate the efficacy and safety of PiXL in the refractive correction of low hyperopia.
详细描述
This clinical study aims to investigate the efficacy and safety of PiXL in the refractive correction of low hyperopia.Slightly modified settings from previously published study is applied to eyes with low hyperopia with an expected refractive change of 0.75 D. Aim is to evaluate the refractive outcome of this procedure.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •low hyperopia of spherical equivalent from +0.5 up to +1.75 D sp. eq.
- •astigmatism up to 0.75 Dcyl
- •corneal thickness above 400 µm
- •endothelial cell density above 1500 cell/mm2
排除标准
- •any prior corneal surgery or any eye surgery within the last 3 months,
- •any corneal pathology e.g. corneal scar or dystrophy
- •unstable refraction
- •patient not able to understand and sign informed consent
- •patients with connective tissue disorder or uncontrolled diabetes
- •pregnant or lactating women
- •aphakic eyes or pseudophakic eyes without UV blocking IOL
结局指标
主要结局
Change in Subjective Refraction
时间窗: Month 12
Spherical and cylindrical correction
Change in Uncorrected Distance Visual Acuity
时间窗: Month 12
Best distance visual acuity tested without any correction
次要结局
- Change in pachymetry(Month 12)
- Change in Higher Order Aberrations(Month 12)
- Change in keratometry(Month 12)
- Subjective questionnaire score(Month 12)
- Change in Corrected Distance Visual Acuity(Month 12)
- Change in Spherical aberration(Month 12)
研究者
研究点 (2)
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