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

NCT06477081 | Recruiting DMC

• 1 other identifier: CI-017-2024
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia; Astigmatism; Myopic Astigmatism

Keywords

KLEx; LASIK; FS-LASIK; Refractive Surgery; Astigmatism; Myopia

Outcome Measures

Primary Outcomes (1)

• Uncorrected Visual Acuity

  Visual acuity without correction after surgery.

  Day 1, week 1, months 1, 3, 6 & 12th after surgery.

Secondary Outcomes (4)

• Postoperative spherical equivalent

  Day 1, week 1, months 1, 3, 6 & 12th after surgery.

• Corrected Distance Visual Acuity

  Day 1, week 1, months 1, 3, 6 & 12th after surgery.

• Loss of 2 or more lines of BCVA

  Day 1, week 1, months 1, 3, 6 & 12th after surgery.

• Eyes with 0.5 Diopters within refractive target.

  Day 1, week 1, months 1, 3, 6 & 12th after surgery.

Other Outcomes (1)

• Adverse events.

  Through study completion, an average of 1 year

Study Arms (2)

FemtoLASIK

ACTIVE COMPARATOR

For the FS-LASIK technique, the following steps will be followed: application of topical anesthesia to mitigate discomfort and pain throughout the procedure, and the patient will be covered with a sterile drape. Subsequently, the patient will be aligned to artificially flatten the entire corneal surface, ensuring head stability with a slight tilt to optimize surgical access and avoid nasal interference. The femtosecond laser system use will be the ATOS operating system (Schwind eye-tech-solutions, Mainparkstraße 6-10, 63801 Kleinostheim, Germany), which is responsible for creating a corneal incision to create the flap, with controlled precision to ensure proper separation of corneal layers. The excimer laser will be the Amaris (Schwind eye-tech-solutions, Mainparkstraße 6-10, 63801 Kleinostheim, Germany), responsible for performing refractive correction on the cornea through selective photoablation. Following photoablation, the flap will be carefully repositioned, and upon completion

Procedure: FS-LASIK procedure

Keratorefractive lenticule extraction

ACTIVE COMPARATOR

For the KLEx technique, the following steps will be followed: after topical anesthesia, a sterile drape is placed over the patient, and a speculum is inserted into the eye, centered, and aligned with a curved interface cone before applying suction. The laser used will be the ATOS operating system (Schwind eye-tech-solutions, Mainparkstraße 6-10, 63801 Kleinostheim, Germany), which performs photo-dissection starting from the posterior surface of the refractive lenticule, followed by the creation of the lenticule edge. The anterior surface of the refractive lenticule is formed by extending beyond the posterior diameter of the lenticule by 0.5 mm to form the anterior flap, followed by a peripheral cut. Specific FS laser parameters are employed for each patient. Subsequently, the suction is released, and a Siebel spatula is used to separate and reflect the flap. Finally, the refractive lenticule is extracted using toothless forceps through the small incision. Once the procedure is complet

Procedure: KLEx

Interventions

FS-LASIK procedure PROCEDURE

For the FS-LASIK technique, the following steps will be followed: application of topical anesthesia to mitigate discomfort and pain throughout the procedure, and the patient will be covered with a sterile drape. Subsequently, the patient will be aligned to artificially flatten the entire corneal surface, ensuring head stability with a slight tilt to optimize surgical access and avoid nasal interference. The femtosecond laser system use will be the ATOS operating system (Schwind eye-tech-solutions, Mainparkstraße 6-10, 63801 Kleinostheim, Germany), which is responsible for creating a corneal incision to create the flap, with controlled precision to ensure proper separation of corneal layers. The excimer laser will be the Amaris (Schwind eye-tech-solutions, Mainparkstraße 6-10, 63801 Kleinostheim, Germany), responsible for performing refractive correction on the cornea through selective photoablation. Following photoablation, the flap will be carefully repositioned, and upon completion o

FemtoLASIK

KLEx PROCEDURE

For the KLEx technique, the following steps will be followed: after topical anesthesia, a sterile drape is placed over the patient, and a speculum is inserted into the eye, centered, and aligned with a curved interface cone before applying suction. The laser used will be the ATOS operating system (Schwind eye-tech-solutions, Mainparkstraße 6-10, 63801 Kleinostheim, Germany), which performs photo-dissection starting from the posterior surface of the refractive lenticule, followed by the creation of the lenticule edge. The anterior surface of the refractive lenticule is formed by extending beyond the posterior diameter of the lenticule by 0.5 mm to form the anterior flap, followed by a peripheral cut. Specific FS laser parameters are employed for each patient. Subsequently, the suction is released, and a Siebel spatula is used to separate and reflect the flap. Finally, the refractive lenticule is extracted using toothless forceps through the small incision. Once the procedure is complete

Keratorefractive lenticule extraction

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Instituto de Oftalmología Fundación Conde de Valenciana: lead

Study Sites (1)

Instituto de Oftalmología Conde de Valenciana

Mexico City, 06800, Mexico

RECRUITING

Related Publications (4)

• Pradhan KR, Arba Mosquera S. SmartSight Correction of Compound Myopic Astigmatism Treatments With Preoperative Astigmatism > 1.00 Diopter Using the SCHWIND ATOS: A Retrospective Case Series. J Refract Surg. 2024 May;40(5):e328-e335. doi: 10.3928/1081597X-20240415-02. Epub 2024 May 1.

  PMID: 38717080 BACKGROUND

• Igras E, Czarnota-Nowakowska B, O'Caoimh R. Comparison of the Clinical Effectiveness of Correcting Different Types of Astigmatism with Small Incision Lenticule Extraction. J Clin Med. 2023 Nov 6;12(21):6941. doi: 10.3390/jcm12216941.

  PMID: 37959406 BACKGROUND

• Foo VHX, Liu YC, Ang M, Htoon HM, Ting DSJ, Mehta JS. Comparative Study of Primary SMILE, SMILE Enhancement, and Femtosecond Laser-Assisted LASIK on Higher Order Aberrations and Corneal Densitometry. J Refract Surg. 2024 May;40(5):e291-e303. doi: 10.3928/1081597X-20240314-01. Epub 2024 May 1.

  PMID: 38717083 BACKGROUND

• Muleiro-Alvarez M, Vera-Duarte GR, Medina-Estrada EA, Ortiz-Morales G, Ramirez-Miranda A, Navas A, Graue-Wiechers EL, Graue-Hernandez EO, Kahuam-Lopez N. 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. BMJ Open. 2025 Dec 23;15(12):e097192. doi: 10.1136/bmjopen-2024-097192.

  PMID: 41436254 DERIVED

MeSH Terms

Conditions

Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

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

CONTACT

+525554421700; nicolas.kahuaml@anahuac.mx

Mauricio Muleiro, MD

CONTACT

mauricio.muleiro@anahuac.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Allocation sequence concealment will be done with sealed opaque envelopes. The envelope will be open prior to the intervention only to surgical team. The technique will not be known by the patient or the staff responsible of the follow-up.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 27, 2024
• Study Start: August 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)