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临床试验/NCT06540131
NCT06540131已完成不适用

The Impact of Ethyle Alcohol Contact Time on Corneal Epithelial Healing in Cases of Photorefractive Keratectomy

Minia University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年3月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
epithelial healing

研究概览

简要总结

The goal of this observational study is to learn about the effects of the duration of ethanol contact with the corneal surface. The main question it aims to answer is: Does this affect the behavior of corneal epithelial healing?

详细描述

The study was carried out on 70 patients who were candidates for laser corneal refractive surgery with alcohol-assisted PRK. The study comprised two groups. Group 1 included the right eye of the patients, and Group 2 included the left eye of the same patients. Group 1 was operated with PRK with alcohol 20% applied for 15 seconds, while group 2 underwent PRK with alcohol 20% applied for 30 seconds. Mitomycin C (MMC) 0.02% was applied for 30 seconds after the laser ablation in both groups.

Inclusions criteria:

The included patients should meet the following criteria: age between 18 and 35 years, both genders, with normal corneal topography, clear cornea, and stable refractive error for at least 12 months before the surgery. Both eyes should have low to moderate myopia with spherical error of more than -4D spherical error, cylindrical error of more than -1.5D, and an estimated stromal ablation depth of less than 70 µm.

Exclusion criteria:

The patients were excluded from the study if they had one or more of the following findings: patients with mixed astigmatism in either eye, contact lens wearers, abnormal corneal topography, thin cornea less than 500 microns, corneal opacity, dry eye disease, history of herpetic keratitis, corneal epithelial pathology (dystrophies or scarring), atopy, collagen diseases, autoimmune disease, systemic diseases that interfere with healing (e.g. diabetes mellitus), eyelid diseases, ocular pathology, previous history of refractive or corneal surgery, and pregnant or lactating females. Also, patients who failed to attend the follow-up visits were excluded.

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •The included patients should meet the following criteria: age between 18 and 35 years, both genders, with normal corneal topography, clear cornea, and stable refractive error for at least 12 months before the surgery. Both eyes should have low to moderate myopia with spherical error of more than -4D spherical error, cylindrical error of more than -1.5D, and an estimated stromal ablation depth of less than 70 µm.

排除标准

  • •The patients were excluded from the study if they had one or more of the following findings: patients with mixed astigmatism in either eye, contact lens wearers, abnormal corneal topography, thin cornea less than 500 microns, corneal opacity, dry eye disease, history of herpetic keratitis, corneal epithelial pathology (dystrophies or scarring), atopy, collagen diseases, autoimmune disease, systemic diseases that interfere with healing (e.g. diabetes mellitus), eyelid diseases, ocular pathology, previous history of refractive or corneal surgery, and pregnant or lactating females. Also, patients who failed to attend the follow-up visits were excluded.

结局指标

主要结局

epithelial healing

时间窗: The patients were folllowed daily upto 2 weeks

assessment of the time at which corneal epithelium is completely healed after PRK surgery

次要结局

未报告次要终点

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ismail Omar

Associate professor of ophthalmology

Minia University

研究点 (1)

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