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临床试验/NCT02210793
NCT02210793已完成不适用

Evaluation of Dry Eye Following Transepithelial Photorefractive Keratectomy in Comparison to Conventional LASIK: a Comparative Study

AL-Nour Eye Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
qualitative assessment of dry eye syndrome

研究概览

简要总结

The aim of the study is to evaluate the severity of dry eye syndrome following excimer laser vision correction using no-touch all-laser photorefractive keratectomy in comparison to conventional lasik

详细描述

Prospective interventional clinical study 2 groups: Group A : 20 eyes of 10 patients undergoing transepithelial PRK Group B: 20 eyes of 10 patients undergoing LASIK using mechanical microkeratome Tear Break Up Time and Schirmer 2 tests are used to evaluate severity of dry eye before surgery and 1 , 3 and 6 months postoperative Follow up period : 6 months

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

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

入选标准

  • Myopia -1 to -6 diopters
  • Astigmatism -0.5 to - 4 diopters

排除标准

  • Pregnancy and lactation
  • Keratoconus
  • Previous refractive surgery
  • Previous herpetic keratitis

研究组 & 干预措施

Transepithelial PRK

Active Comparator

20 eyes to undergo a no touch , all-laser advanced surface ablation technique termed transepithelial PRK using the Amaris laser platform (Schwind eye-tech solutions Gmbh, Germany)

干预措施: transepithelial PRK (Procedure)

Conventional LASIK

Active Comparator

20 eyes to undergo LASIK using a mechanical microkeratome (M2, Moria Surgical, Antony, France) and the Mel 80 excimer laser system(Carl Zeiss Meditec)

干预措施: LASIK (Procedure)

结局指标

主要结局

qualitative assessment of dry eye syndrome

时间窗: 6 months

Tear Break Up time is used as a qualitative measure of dry eye after surgery

quantitative of dry eye after surgery

时间窗: 6 months

Schirmer test is used as a quantitative measure of dry eye after surgery

次要结局

  • haze(6 months)

研究者

发起方
AL-Nour Eye Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mohamed Sherif

Dr Ahmed Sherif

AL-Nour Eye Hospital

研究点 (1)

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