Actively Recruiting

Phase Not Applicable
Age: 21Years +
All Genders
Healthy Volunteers
ID06477081

Keratorefractive Lenticule Extraction (KLEx) Versus Femtosecond Laser-assisted in Situ Keratomileusis (FS-LASIK) for Myopia and Compound Myopic Astigmatism Treatment

Led by Instituto de Oftalmología Fundación Conde de Valenciana · Updated on 2025-06-03

80

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare two laser eye surgery methods—FemtoLASIK and keratorefractive lenticule extraction (KLEx)—for correcting vision problems such as myopia and compound myopic astigmatism. FemtoLASIK involves creating a flap in the cornea and reshaping it, while KLEx corrects vision by creating and removing a lenticule without making a flap. The study evaluates the safety and effectiveness of these two procedures in patients with these vision issues. Participants will be randomly assigned to one of two groups: the FS-LASIK group or the KLEx group. FS-LASIK involves applying topical anesthesia, creating a corneal flap with a femtosecond laser, reshaping the cornea with an excimer laser, and repositioning the flap. KLEx also starts with topical anesthesia but involves creating and extracting a lenticule through a small incision without a flap, using specialized laser techniques. Both procedures use laser systems from Schwind eye-tech-solutions. After surgery, participants will be followed at day 1, week 1, and months 1, 3, 6, and 12. During the study, participants will undergo vision tests including uncorrected and corrected distance visual acuity and measurements of their refractive error at each follow-up visit. Researchers will monitor the precision of vision correction, quality of vision, and any adverse events after surgery. The main outcome is how closely the postoperative vision matches the intended correction at each time point. The entire follow-up period lasts up to 12 months after surgery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 21Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 21 years or older
  • Corneal tomography without alterations
  • Myopia between -0.50 and -12.00 diopters
  • Astigmatism between -0.50 and -6.00 diopters
Not Eligible

You will not qualify if you...

  • Previous eye surgeries
  • Pregnancy
  • Progressive or unstable myopia and/or compound myopic astigmatism
  • Ocular surface disease

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 day

Participants undergo either the KLEx or FS-LASIK refractive surgery procedure to correct myopia or compound myopic astigmatism.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - 12 months

Participants are followed to assess visual acuity, refractive outcomes, and safety at multiple time points after surgery.

6 visits: Day 1, Week 1, and Months 1, 3, 6, and 12 (all in-person)

Trial Site Locations

Total: 1 location

1

Instituto de Oftalmología Conde de Valenciana

Mexico City, Mexico, 06800

Actively Recruiting

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Research Team

N

Nicolas Kahuam, M.D., Ph.D.

M

Mauricio Muleiro, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

SmartSight Correction of Compound Myopic Astigmatism Treatments With Preoperative Astigmatism > 1.00 Diopter Using the SCHWIND ATOS: A Retrospective Case Series.

Kishore Raj Pradhan, Samuel Arba Mosquera

https://pubmed.ncbi.nlm.nih.gov/38717080

Comparison of the Clinical Effectiveness of Correcting Different Types of Astigmatism with Small Incision Lenticule Extraction.

Estera Igras, Barbara Czarnota-Nowakowska, Rónán O'Caoimh

https://pubmed.ncbi.nlm.nih.gov/37959406

Comparative Study of Primary SMILE, SMILE Enhancement, and Femtosecond Laser-Assisted LASIK on Higher Order Aberrations and Corneal Densitometry.

Valencia Hui Xian Foo, Yu-Chi Liu, Marcus Ang...

https://pubmed.ncbi.nlm.nih.gov/38717083

Keratorefractive lenticule extraction (KLEx) versus femtosecond laser-assisted in situ keratomileusis (FS-LASIK) for the treatment of myopia and compound myopic astigmatism: study protocol of a randomised clinical trial in Mexico.

Mauricio Muleiro-Alvarez, Guillermo Raul Vera-Duarte, Eber A Medina-Estrada...

https://pubmed.ncbi.nlm.nih.gov/41436254