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

Sponsor
Singapore Eye Research Institute
Study ID
NCT07505264
Status
Recruiting
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Conditions

  • Myopia

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SMILE surgery with Visumax 500 — PROCEDURE
    Routinely conducted procedure using Visumax 500 laser system for correction of myopia.
  • SMILE surgery with Visumax 800 — PROCEDURE
    Routinely conducted procedure using Visumax 800 laser system for correction of myopia.

Study Details

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.

Key Dates

First listed
Apr 1, 2026
Start date
Dec 1, 2025
Status verified
Mar 2026
Primary completion
May 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Eyes that have undergone SMILE with Visumax 500
    Eyes that have undergone SMILE using Visumax 500 laser system
  • Active Comparator: Eyes that have undergone SMILE with Visumax 800
    Eyes that have undergone SMILE using Visumax 800 laser system

Primary Outcome Measure

Visual outcomes [ Time Frame: 1 year ]

Central Contacts

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