Comparison of Myopic Small Incision Lenticule Extraction (SMILE) With VISUMAX 500 Versus VISUMAX 800 Platforms

Recruiting now · Not applicable

Conditions studied: Myopia

In brief

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.

Key facts

Study ID

NCT07505264

Run by

Singapore Eye Research Institute

People needed

100

Starts

2025-12-01

Expected to finish

2027-06-01

Last updated by the study team

2026-04-01

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Singapore National Eye Centre (SNEC) — Singapore, Singapore (enrolling)

Full record on ClinicalTrials.gov

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