Actively Recruiting
Comparison of Femto LDV Z8 Corneal Lenticule Extraction for Advanced Refractive Correction (CLEAR) and Visumax Small Incision Lenticule Extraction (SMILE)
Led by Singapore Eye Research Institute · Updated on 2025-01-14
65
Participants Needed
1
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Comparison of Femto LDV Z8 Corneal Lenticule Extraction for Advanced Refractive Correction (CLEAR) and Visumax Small Incision Lenticule Extraction (SMILE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 21 to 50 years
- Cycloplegic spherical equivalent greater than -1.00 diopters
- Refractive cylinder of -2.00 diopters or less; anisometropia less than 1.00 diopter
- Best spectacle corrected visual acuity of 6/12 or better in both eyes
- Spherical or cylindrical error progression of -0.50 diopters or less per year from baseline
- Contact lens wearers must have removed lenses at least two weeks before baseline measurement
- No irregular astigmatism on corneal topography
- Able to attend post-operative exams for 12 months
You will not qualify if you...
- Progressive or unstable myopia or astigmatism
- Clinical or topographic signs of keratoconus
- Desire to have bilateral SMILE procedure
- Desire to store extracted corneal lenticule for future surgery
- Residual, recurrent, or active eye diseases such as uveitis, severe dry eyes, severe allergic eye disease, glaucoma, cataract, or retinal disease
- Previous corneal surgery or trauma within the treatment zone
- Corneal vascularization within 1mm of treatment zone
- Taking systemic medications that affect wound healing like corticosteroids or antimetabolites
- Being immunocompromised systemically
- Systemic diseases affecting wound healing, including diabetes, connective tissue disease, or severe atopy
- Pregnant or nursing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Singapore National Eye Centre
Singapore, Singapore, S169856
Actively Recruiting
Research Team
J
Jodhbir S Mehta, MD, FRCS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here