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Comparison of Femto LDV Z8 Corneal Lenticule Extraction for Advanced Refractive Correction (CLEAR) and Visumax Small Incision Lenticule Extraction (SMILE)
Sponsor: Singapore Eye Research Institute
Summary
This observational study aims to compare two laser corrective procedures for treating myopia and myopic astigmatism: a novel refractive technique, the CLEAR procedure, and the established SMILE procedure. Participants will be randomized to undergo CLEAR in one eye and SMILE in the other. The investigators will evaluate and compare the two procedures based on the following aspects: refractive predictability (how accurate the vision correction is) by measuring the proportion of eyes close to the target prescription after surgery, clinical dry eye outcomes, changes in tear proteins, and corneal nerve changes at 1, 3, 6, and 12 months after both surgeries. Metabolomic features of the removed corneal tissue and how precisely the laser is centered during surgery will also be examined. Our hypothesis is that CLEAR provides equally good vision results as SMILE, and explore any extra benefits of CLEAR.
Key Details
Gender
All
Age Range
21 Years - 50 Years
Study Type
OBSERVATIONAL
Enrollment
65
Start Date
2023-03-01
Completion Date
2025-12-31
Last Updated
2025-01-14
Healthy Volunteers
Yes
Conditions
Interventions
Procedure: Corneal lenticule extraction for advanced refractive correction (CLEAR)
Routinely conducted procedure using FEMTO LDV Z8 laser system for correction of Myopia.
Procedure: Small Incision Lenticule Extraction (SMILE)
Routinely conducted procedure using VisuMax laser system for correction of Myopia.
Locations (1)
Singapore National Eye Centre
Singapore, Singapore