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

ConditionMyopia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorSingapore Eye Research Institute

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

Treatment groups

100 Participants
are divided into 2 treatment groups