Health Condition 1: null- Healthy patients of 18 years and above who want to undergo myopic small incision lenticule extraction (SMILE) for correction of refractive error
Conditions
Interventions
Intervention1: Small incision lenticule extraction (SMILE) surgery: SMILE surgery will be performed using a femtosecond laser to remove a lenticule of desired shape. The shape will be such that myopic
Sponsors
Narayana Nethralaya
Eligibility
Inclusion criteria
Inclusion criteria: 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 8. Spherical equivalent difference of 9. For contact lens wearers - Spherical equivalent difference of Soft (extended and daily wear) for 3 days Rigid Gas Permeable (RGP) or Toric for 2 weeks Hard polymethyl methacrylate (PMMA) for 3 weeks
Exclusion criteria
Exclusion criteria: 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 µm. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uncorrected and corrected distance visual acuityTimepoint: Uncorrected and corrected distance visual acuity | — |
Secondary
| Measure | Time frame |
|---|---|
| Wavefront aberrations, â?¢ Corneal endothelial examination, dry eyeTimepoint: Preoperative, 1 week, 1 month, 3 month and 6 month | — |
Countries
India
Contacts
Public ContactRohit Shetty
Narayana Nethralaya
Outcome results
None listed