Comparison of Myopic Small Incision Lenticule Extraction (SMILE) With VISUMAX 500 Versus VISUMAX 800 Platforms
Singapore Eye Research Institute
100 participants
Dec 1, 2025
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria6
- 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
- Contact lens wearers must have removed contact lenses at least 2 weeks before the baseline measurement
- No evidence of irregular astigmatism on corneal topography in both eyes
Exclusion Criteria7
- 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 1 mm of the corneal flap zone
- 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
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Interventions
Routinely conducted procedure using Visumax 500 laser system for correction of myopia.
Routinely conducted procedure using Visumax 800 laser system for correction of myopia.
Locations(1)
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NCT07505264