About this trial
Small incision lenticule extraction (SMILE) procedure is a well-known procedure for the correction of myopia. The purpose of this research study is to compare the two SMILE procedures with different laser platforms (VISUMAX 500 and VISUMAX 800) used for the correction of short-sightedness. The VISUMAX 800 and VISUMAX 500 perform the same procedure, but the VISUMAX 800 is a newer platform. This study is being done to see if the newer VISUMAX 800 provides the same or better results than the VISUMAX 500.
Eligibility criteria
Qualifiers
Cycloplegic spherical equivalent of >-1.00D
Refractive cylinder -2.00 D or less; anisometropia <1.00D
Best spectacle corrected visual acuity (BSCVA) of 6/12 or better in both eyes
Spherical or cylindrical error has progressed at -0.50 D or less per year from date of baseline measurement in both eyes
Disqualifiers
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
Trial design
Treatments tested in this trial
- SMILE surgery with Visumax 500
- SMILE surgery with Visumax 800