CTRI/2017/01/007724OtherUnknown
Comparison of Topography Guided LASIK with WaveLight EX500 to SMILE with Zeiss VisuMax
Alcon laboratories India pvt Ltd0 个研究点目标入组 450 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- Other
- 发起方
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Ocular criteria must be met in both eyes.
- •1. Subjects 18 years of age or older.
- •2. Able to comprehend and sign an informed consent form (ICF).
- •3. Willing and able to complete all post-surgery visits.
- •4. 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
- •1. Pregnancy or lactation, current or planned, during the course of the study.
- •2. Manifest refraction astigmatism that is more than 1.00 D than the topolyzer astigmatism assessed by Topolyzer Vario.
- •3. Mixed astigmatism refractive error.
- •4. Degenerations of structure of the cornea including diagnosed keratoconus, forme fruste kerataconus or pellucid marginal degeneration.
- •5. Dry eye as identified by the short questionnaire for dry eye syndrome (SQDES).
- •6. A calculated residual stromal bed thickness that is less than 250 μm.
- •7. History or evidence of active or inactive corneal or other anterior segment disease (e.g, herpes simplex keratitis, recurrent erosion
- •8. Diagnosed advanced glaucoma.
- •9. Uncontrolled diabetes.
- •10. Nystagmus or any other condition that would prevent a steady gaze during the treatment.
- •11. Previous intraocular or corneal surgery.
- •12. Weakened immune system, including diagnosed collagen vascular, autoimmune or immunodeficiency disease.
- •13. Systemic medications that may affect corneal healing including,but not limited to steroids, antimetabolites, immune response modifying drugs, etc.
- •14. 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.
- •15. Any subject currently participating in another investigational drug or device study that may confound the results of this investigation.
- •16. A known sensitivity to medications used during the study.
研究者
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