CTRI/2017/01/007724Other不适用
Comparison of Topography Guided LASIK with WaveLight EX500 to SMILE with Zeiss VisuMax
Alcon laboratories India pvt Ltd3 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2017年1月31日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- Other
- 发起方
- 入组人数
- 450
- 试验地点
- 3
- 主要终点
- 1. Percentage of eyes with manifest refraction cylinder ≤ 0.5 D at 3 months
研究概览
简要总结
The Purpose of this study to compare Topography Guided Laser In Situ Keratomileusis (LASIK) corneal surgery to Small Incision Lenticlule Extraction (SMILE) corneal surgery for the treatment of myopia with astigmatism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria: Ocular criteria must be met in both eyes.
- •Subjects 18 years of age or older.
- •Able to comprehend and sign an informed consent form (ICF).
- •Willing and able to complete all post-surgery visits.
- •Myopia requiring (a) refractive error correction of -0.5 to -8.0 D manifest refraction sphere with (b) astigmatism correction of -0.75 to -5.0 D manifest refraction cylinder and (c) at least 0.75 D of corneal astigmatism.
排除标准
- •Pregnancy or lactation, current or planned, during the course of the study.
- •Manifest refraction astigmatism that is more than 1.00 D than the topolyzer astigmatism assessed by Topolyzer Vario.
- •Mixed astigmatism refractive error.
- •Degenerations of structure of the cornea including diagnosed keratoconus, forme fruste kerataconus or pellucid marginal degeneration.
- •Dry eye as identified by the short questionnaire for dry eye syndrome (SQDES).
- •A calculated residual stromal bed thickness that is less than 250 μm.
- •History or evidence of active or inactive corneal or other anterior segment disease (e.g, herpes simplex keratitis, recurrent erosion syndrome).
- •Diagnosed advanced glaucoma.
- •Uncontrolled diabetes.
- •Nystagmus or any other condition that would prevent a steady gaze during the treatment.
- •Previous intraocular or corneal surgery.
- •Weakened immune system, including diagnosed collagen vascular, autoimmune or immunodeficiency disease.
- •Systemic medications that may affect corneal healing including,but not limited to steroids, antimetabolites, immune response modifying drugs, etc.
- •Presence or history of any condition or finding that makes the subject unsuitable as a candidate for refractive surgery or study participation or may confound the outcome of the study, in the opinion of the Investigator.
- •Any subject currently participating in another investigational drug or device study that may confound the results of this investigation.
- •A known sensitivity to medications used during the study.
结局指标
主要结局
1. Percentage of eyes with manifest refraction cylinder ≤ 0.5 D at 3 months
时间窗: on the day of the surgery (i.e. Visit 00)
次要结局
- 1. Mean manifest refraction cylinder at 3 months.(2. Mean UCVA at 3 months)
研究者
研究点 (3)
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