Comparing two laser procedures for treating myopia
Comparison of Femto LDV Z8 Corneal Lenticule Extraction for Advanced Refractive Correction (CLEAR) and Visumax Small Incision Lenticule Extraction (SMILE)
This study is testing two different laser treatments for nearsightedness to see which one works better and has fewer side effects.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 65 (estimated) |
| Ages | 21 Years to 50 Years |
| Sex | All |
| Sponsor | Singapore Eye Research Institute Academic / other |
| Locations | 1 site (Singapore) |
| Trial ID | NCT06774651 on ClinicalTrials.gov |
What this trial studies
This observational study compares two laser corrective procedures for myopia: the novel CLEAR technique and the established SMILE procedure. Participants will be randomized to receive CLEAR in one eye and SMILE in the other, allowing for direct comparison of outcomes. The study will evaluate refractive predictability, clinical dry eye outcomes, changes in tear proteins, and corneal nerve changes over a 12-month period. Additionally, the metabolomic features of the removed corneal tissue and laser centering precision will be assessed to determine the effectiveness of each procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 to 50 with myopia or myopic astigmatism who meet specific refractive criteria.
Not a fit: Patients with progressive or unstable myopia, keratoconus, or those seeking bilateral SMILE procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into which laser procedure offers better vision correction and fewer complications for patients with myopia.
How similar studies have performed: While SMILE has been established as effective, the CLEAR technique is novel and its comparative effectiveness is yet to be fully explored.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Singapore
- Singapore National Eye Centre — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Jodhbir S Mehta, MD, FRCS — Singapore National Eye Centre
- Study coordinator: Jodhbir S Mehta, MD, FRCS
- Email: jodhbir.s.mehta@singhealth.com.sg
- Phone: 6322 7478
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.