KLEx Versus FS-LASIK for the Treatment of Myopia and Compound Myopic Astigmatism

Not Applicable

Recruiting

• Conditions: Myopia; Astigmatism; Myopic Astigmatism

• Registration Number: NCT06477081
• Lead Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana

Brief Summary

FemtoLASIK is a type of laser eye surgery used to correct vision problems such as nearsightedness, farsightedness, and astigmatism. It involves two main steps: creating a flap and reshaping the cornea. Refractive lenticule extraction, (KLEx) is another laser eye surgery method to correct vision issues, which involves creating and extracting a lenticule without the need of a flap. The investigators will evaluate and compare the efficacy and safety of these two procedures.

Detailed Description

Keratorefractive lenticule extraction (KLEx) is a refractive surgery technique that does not require the creation of a flap to correct the defects. The potential advantages of this technique are related to the absence of a flap, which could make it the gold standard of refractive surgery. On the other hand, femtosecond-assisted laser in-situ keratomileusis (FS-LASIK) is the most widely practiced refractive surgery worldwide, as it offers excellent visual outcomes but does require the creation of a flap to correct the defects. The objective of this study is to evaluate the effectiveness and safety of KLEx versus FS-LASIK as a treatment option in patients with myopia or compound myopic astigmatism. This is a prospective randomized study. A total of 80 participants will be randomized into two groups, the KLEx group and FS-LASIK group. Following randomization, participants will be followed on the first day after the surgery, 1 week, 1, 3, 6, and 12 months. The primary outcome is the refractive predictability at every postoperative point after surgery, which is the proportion of the number of eyes achieving a postoperative spherical equivalent within ± 0.5 diopters of the intended target. Secondary outcome parameters include quality vision measurements, refraction, visual acuity, and adverse events.

Study Timeline

• Study First Submitted: 2024-06-17
• Study First Submitted QC: 2024-06-24
• Study First Posted: 2024-06-27
• Study Start: 2024-08-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-28
• Last Update Posted: 2025-06-03
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Uncorrected Visual Acuity	Day 1, week 1, months 1, 3, 6 & 12th after surgery.	Visual acuity without correction after surgery.

Secondary Outcome Measures

Name	Time	Method
Loss of 2 or more lines of BCVA	Day 1, week 1, months 1, 3, 6 & 12th after surgery.	Loss of 2 or more lines of best corrected visual acuity
Eyes with 0.5 Diopters within refractive target.	Day 1, week 1, months 1, 3, 6 & 12th after surgery.	Proportion of eye within 0.5 Diopters of refactive target.
Postoperative spherical equivalent	Day 1, week 1, months 1, 3, 6 & 12th after surgery.	Overall refractive power that has both spherical and cylindrical components.
Corrected Distance Visual Acuity	Day 1, week 1, months 1, 3, 6 & 12th after surgery.	Visual acuity after surgery with refractive correction

Trial Locations

Locations (1)

Instituto de Oftalmología Conde de Valenciana; 🇲🇽 Mexico City, Mexico