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临床试验/CTRI/2025/09/095287
CTRI/2025/09/095287尚未招募不适用

Corneal Epithelial Remodeling and Corneal Asphericity after Transepithelial Photorefractive Keratectomy for Myopia and Myopic Astigmatism

Sankara Eye Hospital, Coimbatore1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年10月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
45
试验地点
1
主要终点
Measurement of Changes in corneal epithelial thickness and Q-value (asphericity) using anterior segment OCT post Transepithelial Photorefractive Keratectomy

研究概览

简要总结

This prospective observational study will be conducted at Sankara Eye Hospital, Coimbatore, on 45 patients with myopia or myopic astigmatism undergoing transepithelial photorefractive keratectomy (Trans-PRK) using the Schwind Amaris 1050 excimer laser. The corneal epithelium has a non-uniform thickness and undergoes remodeling after refractive surgery, which can influence corneal curvature, asphericity (Q-value), and visual outcomes. Patients will be followed up at 1 month, 3 months, and 6 months. At each visit, visual acuity, corneal epithelial thickness mapping at central (2 mm), paracentral (2–4 mm), and peripheral (4–6 mm) zones using Anterion, and Q-value analysis will be performed. The primary objective is to evaluate epithelial remodeling and corneal asphericity after Trans-PRK. Secondary objectives include correlation of remodeling with visual acuity and comparison of epithelial remodeling patterns between spherical myopia and myopic astigmatism. The study is expected to provide insights into epithelial healing patterns, their impact on optical quality, and guidance for improving refractive surgery planning and outcomes.

研究设计

研究类型
Observational

入排标准

年龄范围
21.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients 21 to 40 years with Myopia and Myopic astigmatism 2.Patients with stable refraction for atleast 1 year 3.Spherical myopia less than -5.5 D 4.Astigmatism less than -3.5 D.

排除标准

  • 1.Patients with dry eye 2.Patients with corneal scar 3.Patients with thinnest pachymetry value less than 470 microns 4.Patients with co-existing ocular diseases.

结局指标

主要结局

Measurement of Changes in corneal epithelial thickness and Q-value (asphericity) using anterior segment OCT post Transepithelial Photorefractive Keratectomy

时间窗: at baseline, 4 weeks, 12 weeks, and 24 weeks post-Transepithelial Photorefractive Keratectomy

次要结局

  • Correlation between corneal epithelial thickness changes and visual acuity at each postoperative follow-up.
  • Comparison of epithelial remodeling patterns (central, paracentral, and mid-peripheral thickness changes) between Patients with simple myopia and Patients with myopic astigmatism

研究者

发起方
Sankara Eye Hospital, Coimbatore
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Suprita Boodur

Sankara Eye Hospital, Coimbatore

研究点 (1)

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