KLEx versus FS-LASIK to correct nearsightedness and compound myopic astigmatism
Keratorefractive Lenticule Extraction (KLEx) Versus Femtosecond Laser-assisted in Situ Keratomileusis (FS-LASIK) for the Treatment of Myopia and Compound Myopic Astigmatism
This trial will test whether KLEx or FS-LASIK gives better vision correction for adults with nearsightedness and compound myopic astigmatism.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Instituto de Oftalmología Fundación Conde de Valenciana Academic / other |
| Locations | 1 site (Mexico City) |
| Trial ID | NCT06477081 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized trial that will assign 80 adult participants to undergo either KLEx (flap-free refractive lenticule extraction) or femtosecond-assisted LASIK (FS-LASIK, which creates a corneal flap). Participants will be followed on day 1, week 1, and at 1, 3, 6, and 12 months after surgery to measure outcomes. The primary outcome is refractive predictability, defined as the proportion of eyes within ±0.5 diopters of the intended target at each postoperative visit. Secondary outcomes include measures of visual quality, refraction, visual acuity, and recording of adverse events.
Who should consider this trial
Good fit: Adults aged 21 or older with stable myopia between -0.50 and -12.00 D, astigmatism between -0.50 and -6.00 D, and normal corneal tomography are the intended candidates.
Not a fit: People with prior eye surgery, progressive or unstable myopia, ocular surface disease, or who are pregnant are not likely to benefit from participation.
Why it matters
Potential benefit: If successful, KLEx could provide comparable or better vision correction without creating a corneal flap, potentially reducing flap-related issues.
How similar studies have performed: Other flap-free lenticule extraction techniques (for example SMILE) have shown visual outcomes comparable to FS-LASIK in many studies, though flap-free methods remain under active investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 21 years or older * Corneal tomography without alterations * Myopia between -0.50 and -12.00 D * Astigmatism between -0.50 and -6.00 D Exclusion Criteria: * Previous eye surgeries * Pregnancy * Progressive or unstable myopia and/or compound myopic astigmatism * Ocular surface disease
Where this trial is running
Mexico City
- Instituto de Oftalmología Conde de Valenciana — Mexico City, Mexico (Recruiting)
Study contacts
- Study coordinator: Nicolas Kahuam, M.D., Ph.D.
- Email: nicolas.kahuaml@anahuac.mx
- Phone: +525554421700
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.