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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Singapore
Singapore National Eye Centre (SNEC)
RECRUITING
Singapore
Contact Information
Primary
Jodhbir S Mehta, MD, FRCS
jodhbir.s.mehta@singhealth.com.sg
+65 6322 7478
Time Frame
Start Date: 2025-12-01
Estimated Completion Date: 2027-06
Participants
Target number of participants: 100
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Singapore Eye Research Institute

This content was sourced from clinicaltrials.gov