CTRI/2019/07/020437
Not yet recruiting
未知
Assessment of efficacy, patient satisfaction & stereopsis in patients opting for Small Incision Lenticule Extraction (SMILE) monovision
Carl ZEISS India0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Carl ZEISS India
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age \>\=40 yearsâ?¨
- •2\. Myopia 1\.0D to 10 D â?¨
- •3\. Refractive cylinder \-4\.00 DCL or less. â?¨
- •4\. Best spectacle corrected visual acuity (BSCVA) of 6/9 or better in each eye â?¨
- •5\. Stable refraction with less than \-0\.50D spherical or cylindrical error change in last one year.â?¨
- •6\. Contact lens wearers must have removed contact lenses at least two (2\) weeks before the baseline measurement.
- •7\. No evidence of irregular astigmatism on corneal topography. â?¨
- •8\. Available to attend post\-operative examinations for a 12\-month period.
- •9\. Near Add \> 0DSâ?¨
Exclusion Criteria
- •1\. Progressive or unstable myopia and/or astigmatism.â?¨
- •2\. Clinical or corneal topographic evidence of keratoconus.â?¨
- •3\. A residual stromal bed thickness that is less than 275 microns from the corneal endothelium.
- •4\. Residual, recurrent or active ocular disease such as uveitis, severe dry eyes, severe allergic eye disease, glaucoma, visually significant cataract andâ?¨retinal disease.â?¨
- •5\. Previous corneal surgery or trauma.â?¨
- •6\. Taking systemic medications likely to affect wound healing, such as corticosteroids and antimetabolites.â?¨
- •7\. Systemically immunocompromised.â?¨
- •8\. Systemic disease likely to affect wound healing, such as diabetes, connective tissue disease and severe atopy.â?¨
- •9\.Pregnant or nursing.
- •10\. Use of Prisms
Outcomes
Primary Outcomes
Not specified
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