KLEx Versus FS-LASIK for the Treatment of Myopia 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
Instituto de Oftalmología Fundación Conde de Valenciana
80 participants
Aug 1, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria4
- Previous eye surgeries
- Pregnancy
- Progressive or unstable myopia and/or compound myopic astigmatism
- Ocular surface disease
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Interventions
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
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
Locations(1)
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NCT06477081