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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 50
Healthy Volunteers: t
View:

• \>/= 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.

• Spherical or cylindrical error has progressed at -0.50D or less per year from date of baseline measurement.

• Contact lens wearers must have removed contact lenses at least two (2) weeks before the baseline measurement.

• No evidence of irregular astigmatism on corneal topography.

• Available to attend post-operative examinations for a 12-month period.

Locations
Other Locations
Singapore
Singapore National Eye Centre
RECRUITING
Singapore
Contact Information
Primary
Jodhbir S Mehta, MD, FRCS
jodhbir.s.mehta@singhealth.com.sg
6322 7478
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 65
Treatments
1. CLEAR surgery eyes
Eyes that have undergone CLEAR procedures.
2. SMILE surgery eyes
Eyes that have undergone SMILE procedures.
Related Therapeutic Areas
Sponsors
Leads: Singapore Eye Research Institute

This content was sourced from clinicaltrials.gov