Prospective study on SMILE procedure on eyes with refractive error
- Conditions
- 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
- Registration Number
- CTRI/2017/12/010916
- Lead Sponsor
- arayana Nethralaya
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ncorrected and corrected distance visual acuityTimepoint: Uncorrected and corrected distance visual acuity
- Secondary Outcome Measures
Name Time Method Wavefront aberrations, â?¢Corneal endothelial examination, dry eyeTimepoint: Preoperative, 1 week, 1 month, 3 month and 6 month