Correcting refractive error with SMILE

arayana Nethralaya0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Subjects 18 years of age or older.
•2. Able to comprehend and sign an 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.
•5. Intended treatment is targeted for emmetropia.
•6. Pre-surgery BCVA 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) for 3 days
•Rigid Gas Permeable (RGP) or Toric for 2 weeks
•Hard polymethyl methacrylate (PMMA) for 3 weeks

•1. Pregnancy or lactation, current or planned, during the course of the study.
•2. Mixed astigmatism refractive error.
•3. Degenerations of structure of the cornea including diagnosed keratoconus, forme fruste kerataconus or pellucid marginal degeneration.
•4. Dry eye
•5. A calculated residual stromal bed thickness that is less than 250 Âµm.
•6. History or evidence of active or inactive corneal or other anterior segment disease (e.g, herpes simplex keratitis, recurrent erosion syndrome).
•7. Diagnosed advanced glaucoma.
•Uncontrolled diabetes.
•8. Nystagmus or any other condition that would prevent a steady gaze during the treatment.
•9. Previous intraocular or corneal surgery.
•Weakened immune system, including diagnosed collagen vascular, autoimmune or immunodeficiency disease.
•10. Systemic medications that may affect corneal healing including, but not limited to steroids, antimetabolites, immune response modifying drugs, etc.
•11. 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.
•12. Any subject currently participating in another investigational drug or device study that may confound the results of this investigation.
•13. A known sensitivity to medications used during the study.

发起方

arayana Nethralaya