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NCT06774651

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

Recruiting now Last updated 14 January 2025
What this trial tests

trial testing Procedure: Corneal lenticule extraction for advanced refractive correction (CLEAR) in Myopia in 65 participants. Currently enrolling.

Timeline
1 March 2023
Primary endpoint
31 October 2025
31 December 2025

Quick facts

Lead sponsorSingapore Eye Research Institute
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment65
Start date1 March 2023
Primary completion31 October 2025
Estimated completion31 December 2025
Sites1 location across Singapore

Drugs / interventions tested

Conditions studied

Sponsor

Singapore Eye Research Institute

Who can join

Adults 21 to 50, any sex, with Myopia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Randomized controlled trial on corneal denervation, neuroinflammation and ocular surface in corneal lenticule extraction for advanced refractive correction (CLEAR) and small incision lenticule extraction (SMILE).
    Yu M, Liu C, Lee IXY, Hsu VW, et al · · 2025 · cited 1× · PMID 40165267 · DOI 10.1186/s40662-025-00429-1

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Other recruiting trials for Myopia

Currently open trials in the same condition.

Other Singapore Eye Research Institute trials

Trials by the same sponsor.

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Data sources for this page

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