Actively Recruiting

Phase Not Applicable
Age: 21Years +
All Genders
NCT07505264

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

Led by Singapore Eye Research Institute · Updated on 2026-04-01

100

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Cycloplegic spherical equivalent of greater than -1.00 diopters
  • Refractive cylinder of -2.00 diopters or less; anisometropia less than 1.00 diopter
  • Best spectacle corrected visual acuity of 6/12 or better in both eyes
  • Spherical or cylindrical error progression of -0.50 diopters or less per year in both eyes
  • Contact lens wearers must have stopped using lenses at least 2 weeks before baseline measurement
  • No irregular astigmatism seen on corneal topography in both eyes
Not Eligible

You will not qualify if you...

  • Progressive or unstable myopia or astigmatism
  • Signs of keratoconus from clinical or corneal topography exams
  • Active or recurring eye diseases such as uveitis, severe dry eyes, severe allergic eye disease, glaucoma, cataract affecting vision, or retinal disease
  • Previous corneal surgery or trauma within the corneal flap area
  • Corneal blood vessel growth within 1 mm of the corneal flap area
  • Taking medications that affect wound healing, like corticosteroids or antimetabolites
  • Having systemic illnesses that may impair healing, such as diabetes, connective tissue diseases, severe allergies, or being pregnant or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Singapore National Eye Centre (SNEC)

Singapore, Singapore, 169856

Actively Recruiting

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Research Team

J

Jodhbir S Mehta, MD, FRCS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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