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Comparison of Femto LDV Z8 Corneal Lenticule Extraction for Advanced Refractive Correction (CLEAR) and Visumax Small Incision Lenticule Extraction (SMILE)

StatusRecruiting
PhaseNot specified
Started
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Record status
This record was last updated January 14, 2025 (before its estimated October 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT06774651
Lead Sponsor Singapore Eye Research Institute
Conditions
(from sponsor)		 Myopia
Related terms Myopia
Enrollment 65 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov