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RECRUITING
NCT06774651

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

View on ClinicalTrials.gov

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

Procedure: Corneal lenticule extraction for advanced refractive correction (CLEAR)

Routinely conducted procedure using FEMTO LDV Z8 laser system for correction of Myopia.

PROCEDURE

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