SMILE surgery with Visumax 500SMILE surgery with Visumax 800
SMILE surgery with Visumax 500: Routinely conducted procedure using Visumax 500 laser system for correction of myopia.
SMILE surgery with Visumax 800: Routinely conducted procedure using Visumax 800 laser system for correction of myopia.
Study 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
Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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
Primary outcome measure(s)
Visual outcomes — 1 year Best-corrected visual acuity (BCVA), Uncorrected visual acuity (UCVA). Refractive outcomes: Nine standard graphs for corneal refractive surgery: Post-operative UDVA versus pre-operative CDVA; Change in Snellen lines from pre-operative CDVA to post-operative UDVA; Change in Snellen lines from pre-operative CDVA to post-operative CDVA; Attempted versus achieved spherical equivalent refraction; Accuracy of post-operative spherical equivalent refraction to target; Stability of spherical equivalent refraction, shown as the trend of mean Spherical Equivalent (SE) at preop, one week, one month, three months, six months, and one year post-operatively; Change in refractive astigmatism; Target-induced astigmatism (TIA) vs. surgically induced astigmatism (SIA); Histogram of refractive astigmatism angle of error. Refractive predictability, which is defined as the proportion number of eyes achieving a postoperative spherical equivalent (SE) within ±1.0 D of the intended target.
Trial sites (1)
Facility
City
Region
Status
Singapore National Eye Centre (SNEC)
Singapore
Singapore
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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