SMILE with VISUMAX 500 versus VISUMAX 800 for correcting short-sightedness
Comparison of Myopic Small Incision Lenticule Extraction (SMILE) With VISUMAX 500 Versus VISUMAX 800 Platforms
We will try SMILE eye surgery with the newer VISUMAX 800 on one eye and the VISUMAX 500 on the other to see which gives better vision and recovery for people with myopia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Singapore Eye Research Institute Academic / other |
| Locations | 1 site (Singapore) |
| Trial ID | NCT07505264 on ClinicalTrials.gov |
What this trial studies
This randomized contralateral-eye study will enroll 100 patients undergoing bilateral SMILE, with one eye randomized to the VisuMax 500 platform and the fellow eye to the VisuMax 800. The VisuMax 800 incorporates technical upgrades (2 MHz laser frequency, CentraLign centration guidance, OcuLign cyclotorsion compensation, separate laser and microscope arms, and heads-up docking) that could affect surgical precision and patient experience. Outcomes will include objective visual and refractive measures, corneal biomechanical and molecular markers, and patient-reported symptoms and satisfaction over postoperative follow-up. The design allows direct head-to-head comparison within the same patient to minimize intersubject variability.
Who should consider this trial
Good fit: Adults with stable mild-to-moderate myopia who meet SMILE eligibility (healthy corneas, refractive cylinder within limits, good corrected vision, and stable refractions) and who are candidates for bilateral SMILE are ideal.
Not a fit: People with progressive or unstable myopia/astigmatism, corneal ectasia or keratoconus, prior corneal surgery in the flap zone, significant ocular disease, or those outside the refractive limits are unlikely to benefit from this comparison.
Why it matters
Potential benefit: If the VISUMAX 800 performs better, patients could get equal or improved vision with potentially greater procedural precision, comfort, or faster recovery.
How similar studies have performed: Early non-randomized reports show VisuMax 800 outcomes comparable to VisuMax 500, but direct randomized head-to-head comparisons across multiple measures are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Singapore
- Singapore National Eye Centre (SNEC) — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Jodhbir S Mehta, MD, FRCS — Singapore National Eye Centre
- Study coordinator: Jodhbir S Mehta, MD, FRCS
- Email: jodhbir.s.mehta@singhealth.com.sg
- Phone: +65 6322 7478
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.