NCT06774651 Comparison of Femto LDV Z8 Corneal Lenticule Extraction for Advanced Refractive Correction (CLEAR) and Visumax Small Incision Lenticule Extraction (SMILE)
| NCT ID | NCT06774651 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Singapore Eye Research Institute |
| Condition | Myopia |
| Study Type | OBSERVATIONAL |
| Enrollment | 65 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 65 participants in total. It began in 2023-03-01 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * \>/= 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. Exclusion Criteria: * 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. * Residual, recurrent or active ocular disease such as uveitis, severe dry eyes, severe allergic eye disease, glaucoma, visually significant cataract and retinal disease. * Previous corneal surgery or trauma within the corneal treatment zone. * Corneal vascularisation within 1mm of the corneal treatment zone. * Taking systemic medications likely to affect wound healing, such as corticosteroids and antimetabolites. * Systemically immunocompromised. * Systemic disease likely to affect wound healing, such as diabetes, connective tissue disease and severe atopy. * Pregnant or nursing.
Contact & Investigator
Jodhbir S Mehta, MD, FRCS
PRINCIPAL INVESTIGATOR
Singapore National Eye Centre
Frequently Asked Questions
Who can join the NCT06774651 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 50 Years, studying Myopia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06774651 currently recruiting?
Yes, NCT06774651 is actively recruiting participants. Contact the research team at jodhbir.s.mehta@singhealth.com.sg for enrollment information.
Where is the NCT06774651 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT06774651 clinical trial?
NCT06774651 is sponsored by Singapore Eye Research Institute. The principal investigator is Jodhbir S Mehta, MD, FRCS at Singapore National Eye Centre. The trial plans to enroll 65 participants.