Status:
UNKNOWN
Randomized, Non-inferiority Trial Comparing SMILE and LASIK
Lead Sponsor:
Singapore National Eye Centre
Conditions:
Myopia
Astigmatism
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
Background: Small Incision Lenticule Extraction or SMILE is a novel form of 'flapless' corneal refractive surgery that was adapted from Refractive Lenticule Extraction (ReLEx). SMILE uses only one fem...
Detailed Description
Surgical correction for refractive errors may be performed by a number of procedures. Laser correction involves procedures such as EpiLASIK, LASIK or conductive keratoplasty, while lens based correcti...
Eligibility Criteria
Inclusion
- 21 years of age or older.
- Cycloplegic spherical equivalent of \>-2.00D
- Refractive cylinder -4.00 D or less, Anisometropia of \>1D
- Best spectacle corrected visual acuity (BSCVA) of 6/12 or better in BOTH eyes.
- Spherical or cylindrical error has progressed at -0.50D or less per year from date of baseline measurement.
- Contact lens wearers must have removed contact lenses at least two (2) weeks before the baseline measurement.
- No evidence of irregular astigmatism on corneal topography.
- Available to attend post-operative examinations for a 3 month period.
Exclusion
- Progressive or unstable myopia and/or astigmatism.
- Clinical or corneal topographic evidence of keratoconus.
- Residual, recurrent or active ocular disease such as uveitis, severe dry eyes, severe allergic eye disease, glaucoma, visually significant cataract and retinal disease.
- Previous corneal surgery or trauma within the corneal flap zone.
- Patent corneal vascularization within 1mm of the corneal flap zone.
- Taking systemic medications likely to affect wound healing, such as corticosteroids and antimetabolites.
- Systemically immunocompromised.
- Systemic disease likely to affect wound healing, such as diabetes, connective tissue disease and severe atopy.
- Pregnant or nursing.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2017
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01216475
Start Date
February 1 2012
End Date
September 1 2017
Last Update
July 20 2016
Active Locations (1)
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1
Singapore National Eye Centre
Singapore, Singapore, Singapore, 168751