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临床试验/NCT06110286
NCT06110286招募中不适用

Comparison of Corneal High Order Aberrations After Stream Light Trans-PRK and Mechanical Photorefractive Keratectomy

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Corneal high order aberrations measured before and after the intervention by corneal topography machine

研究概览

简要总结

Compare corneal high order aberrations before and after stream light trans-PRK and mechanical photorefractive keratectomy including third order aberrations; Trefoil and coma aberrations and forth order aberrations; spherical aberrations

详细描述

Laser technology has played an important role in promoting the development of ophthalmology, especially corneal refractive surgery.1 Trans-epithelial photorefractive keratectomy (Trans-PRK) has become a highly researched topic in recent years.2 Different epithelial debridement methods with PRK showed favorable results for the surgical treatment of low to moderate myopia3. In mechanical PRK (m-PRK), epithelial debridement is achieved using a blunt spatula, whereas in stream light trans-PRK (t-PRK), there after an excimer laser is used to ablate corneal stroma3. The Stream Light t-PRK is a safe and effective treatment option for the correction of low to moderate myopia.4 Many studies have shown that the corneal asphericity developed significantly after refractive surgeries and introduce higher-order aberrations (HOAs).2 The present study focused on three of the most clinically important HOAs; spherical, coma, and trefoil aberrations, both preoperative and postoperative were recorded from topography over the 6-mm-diameter central corneal zone using Pentacam.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • • Stable refraction for 1 year (refraction does not exceed 1D more than the last prescribed glasses).
  • Discontinuation of soft contact lens wears at least 1 week before examination.
  • Topography criteria:
  • Corneal thickness equal or more than 470 um
  • Symmetrical bow-tie
  • Back elevation not more than +12
  • Normal Belin\Ambrosio Enhanced ectasia display
  • Spherical equivalent not more than -6D.

排除标准

  • • Previous ocular surgery
  • Concurrent ocular pathology; corneal scar, corneal dystrophy
  • Systemic disease; Uncontrolled diabetes, collagen disease
  • Post-operative complications; sub-epithelial haze.

结局指标

主要结局

Corneal high order aberrations measured before and after the intervention by corneal topography machine

时间窗: 1 monthe after surgery

* Third order aberrations; Trefoil and coma aberrations * Forth order aberrations; spherical aberrations Trefoil, spherical and coma aberrations

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Khaled Abdelazeem

Associate professor

Assiut University

研究点 (1)

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