KCT0002308撤回未知
Comparison of Topography Guided LASIK with WaveLight EX500 to SMILE with Zeiss VisuMax
Sungmo Eye Hospital of Sekwang Medical Foundation0 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
- 未知
- 状态
- 撤回
- 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 Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •Below is a list of inclusion criteria. Ocular criteria must be met in both eyes.
- •1. Subjects upon completion of 19 years of age or older.
- •2. Able to comprehend and sign an Informed Consent Form.
- •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.
- •5. Intended treatment is targeted for emmetropia.
- •6. Pre-surgery Best-corrected visual acuity of 0 logarithm of the minimum angle of resolution (logMAR) (20/20) or better.
- •7. Spherical equivalent difference of = 0.5 D between the manifest and cycloplegic refraction outcomes.
- •8. Spherical equivalent difference of = 0.5 D between refractive error corrections for a minimum of 12 months prior to surgery verified by consecutive refractions and/or medical records or prescription history.
- •9. For contact lens wearers - Spherical equivalent difference of = 0.5 D between outcomes from consecutive manifest refraction outcomes performed at least 7 days apart after the contact lens wear has been stopped for the appropriate period of time as follows:
- •Soft (extended and daily wear) = 3 days
- •Rigid Gas Permeable (RGP) or Toric = 2 weeks
- •Hard polymethyl methacrylate (PMMA) = 3 weeks
排除标准
- •Below is a list of exclusion criteria. Ocular criteria must not be met in either eye.
- •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.
- •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 syndrome).
- •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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