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

ConditionMyopia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-50
SponsorSingapore Eye Research Institute

About this trial

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.

Eligibility criteria

Qualifiers

>/= 21 years of age and </= 50 years of age.

Cycloplegic spherical equivalent of >-1.00D

Refractive cylinder -2.00 D or less; anisometropia <1.00D

Best spectacle corrected visual acuity (BSCVA) of 6/12 or better in BOTH eyes.

Disqualifiers

Progressive or unstable myopia and/or astigmatism.

Clinical or corneal topographic evidence of keratoconus.

Patients who want bilateral SMILE procedure

Patients who want extracted corneal lenticule to be stored for future refractive surgery.

Trial design

Treatments tested in this trial

  • Procedure: Corneal lenticule extraction for advanced refractive correction (CLEAR)
  • Procedure: Small Incision Lenticule Extraction (SMILE)

Treatment groups

65 Participants
are divided into 2 treatment groups