Skip to main content

Table 1 Inclusion and exclusion criteria for trial participants

From: Small incision lenticule extraction (SMILE) versus laser in-situ keratomileusis (LASIK): study protocol for a randomized, non-inferiority trial

Inclusion criteria

Exclusion criteria

I. 21 years of age or older

I. Progressive or unstable myopia and/or astigmatism

II. Cycloplegic spherical equivalent of >−3.00 D in BOTH eyes

II. Clinical or corneal topographic evidence of keratoconus

III. Refractive cylinder −2.00 D or less in BOTH eyes and anisometropia of <1D comparing BOTH eyes

III. Residual, recurrent or active ocular disease such as uveitis, severe dry eyes, severe allergic eye disease, glaucoma, visually significant cataract, and retinal disease

IV. Best spectacle corrected visual acuity (BSCVA) of 6/12 or better in BOTH eyes

IV. Previous corneal surgery or trauma within the corneal flap zone

V. Spherical or cylindrical error has progressed at −0.50 D or less per year from date of baseline measurement in BOTH eyes

V. Patent corneal vascularization within 1 mm of the corneal flap zone

VI. Contact lens wearers must have removed contact lenses at least 2 weeks before the baseline measurement

VI. Taking systemic medications likely to affect wound healing, such as corticosteroids and antimetabolites. Systemically immunocompromised or systemic disease likely to affect wound healing, such as diabetes, connective tissue disease, and severe atopy; pregnant or nursing

VII. No evidence of irregular astigmatism on corneal topography in BOTH eyes