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

NCT06774651 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 65

Last updated 2025-01-14

No results posted yet for this study

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.

Conditions

  • Myopia

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.

Sponsors & Collaborators

  • Singapore Eye Research Institute

    lead OTHER

Principal Investigators

  • Jodhbir S Mehta, MD, FRCS · Singapore National Eye Centre

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2025-10-31
Completion
2025-12-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06774651 on ClinicalTrials.gov