SMILE with VISUMAX 500 versus VISUMAX 800 for correcting short-sightedness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating a device for screening vision problems in young children

  This study is testing a new device to see if it can effectively find vision problems in children aged 3 to 8, whether they wear glasses or not.

  Recruiting Essilor International · Nancy, France and 1 other locations · NCT06882408

• Optimizing light exposure to prevent and control myopia in children

  This study tests if changing classroom lighting to mimic sunlight or using a smartphone app to guide light exposure can help prevent and control myopia in primary school children.

  Recruiting at 5 sites National University of Singapore · Singapore and 4 other locations · NCT06631339

• Hyperopic reserve screening for kindergartners in Beijing

  A population-wide screening tests whether senior kindergarten children in Beijing have enough hyperopic reserve to help prevent future myopia.

  Recruiting Beijing Tongren Hospital · Beijing · NCT07851532

• Do dual-focus multifocal contact lenses improve hand-eye coordination and sports vision compared with your usual lenses

  This study tests whether wearing dual-focus multifocal contact lenses improves hand-eye coordination and sports vision in adults who play baseball or softball and normally wear contact lenses.

  Recruiting Ohio State University · Columbus, Ohio · NCT07840209

• Two monthly silicone hydrogel multifocal toric contact lenses in wearers with astigmatism and myopia

  This study tests whether two popular soft multifocal toric contact lenses perform differently in adults who need vision correction for astigmatism and myopia.

  Recruiting CooperVision International Limited (CVIL) · New York, New York and 2 other locations · NCT07829419

• Seeing clearly in low light after Ray-Tracing guided LASIK

  A trial tests how well WaveLight Plus LASIK works for people with myopia and astigmatism and whether patients are satisfied after the procedure.

  Recruiting Phase 4 Vance Thompson Vision · Sioux Falls, South Dakota · NCT07790185

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.