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临床试验/NCT07481227
NCT07481227已完成不适用

Comparative Study of Femtosecond Laser-assisted LASIK and Single-step Transepithelial Photorefractive Keratectomy for Correction of Mixed Astigmatism

Assiut University1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2019年6月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
1
主要终点
Uncorrected distance visual acuity (UDVA)

研究概览

简要总结

Mixed astigmatism is a type of refractive error in which the two principal steep and flat meridians focus the light in front and behind the retina, respectively.1 Laser vision correction (LVC) for mixed astigmatism is challenging as it involves a bitoric ablative pattern to flatten the steepest meridian and steepen the flattest one. The aim of the current study was to compare the visual and refractive outcomes of FS-LASIK versus single-step TransPRK for treatment of patients with mixed astigmatism.

研究设计

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

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Mixed astigmatism (Plus sphere up to +4 diopters D and a minus cylinder up to -6 D).
  • Stable refraction.
  • Clear cornea.
  • Normal corneal tomography.

排除标准

  • Corrected distance visual acuity worse than 20/32 Snellen's acuity.
  • Difference between manifest and cycloplegic refraction ≥ 1 D.
  • Previous corneal or ocular surgeries, other ocular diseases.
  • Systemic diseases including diabetes mellitus and autoimmune diseases.

研究组 & 干预措施

Femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK) group

干预措施: Femtosecond laser-assisted LASIK (Procedure)

Single-step transepithelial photorefractive keratectomy (TransPRK) group

干预措施: Single-step transepithelial PRK (Procedure)

结局指标

主要结局

Uncorrected distance visual acuity (UDVA)

时间窗: 24 months

Visual acuity measurement using Snellen's Acuity Chart converted to logMAR notation.

Corrected distance visual acuity (CDVA)

时间窗: 24 months

Corrected visual acuity measurement using Snellen's Acuity Chart and converted to logMAR notation.

Postoperative refraction

时间窗: 24 months

Manifest sphere and cylinder measured by Topcon Auto-Keratorefractometer

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

Mahmoud Abdel-Radi

Professor

Assiut University

研究点 (1)

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