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临床试验/CTRI/2015/01/005472
CTRI/2015/01/005472已完成未知

Visual and Refractive Outcomes with ReLEx® SMILE in 600 Eyes

ethradhama Superspeciality Eye Hospital0 个研究点目标入组 300 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
已完成
发起方
入组人数
300

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

入选标准

  • myopia between 1 to 10 diopters (D), astigmatism upto 5D, and spherical equivalent upto 10D, an age of 21 years or older, a stable refraction for atleast 1 year, the discontinuation of soft contact lenses for a minimum of 1 week and rigid gas permeable contact lens discontinuation for a minimum of 3 weeks, a minimum corneal thickness of 480µm, a residual corneal thickness of atleast 250µm or 50% of original thickness (whichever was higher), the ability to understand and a willingness to sign informed consent, and a willingness to participate in all follow-up visits.

排除标准

  • eyes with evidence of ocular disease such as meibomian gland disease, herpetic keratitis, uveitis, glaucoma, visually significant cataract, retinal diseases like retinal dystrophies or diabetic retinopathy, progressive/unstable myopia or astigmatism, corneal dystrophies, keratoconus, any history of corneal trauma or surgery, dry eye status(demonstrated by a Schirmerâ??s 2 test value of less than 10 mm), the use of any systemic medication likely to affect wound healing (e.g., corticosteroids or antimetabolites), an immunocompromised state, and patients who were pregnant or nursing mothers.

研究者

发起方
ethradhama Superspeciality Eye Hospital

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