Clinical trial NCT06477081: KLEx Versus FS-LASIK for the Treatment of Myopia and Compound Myopic Astigmatism
Official title: Keratorefractive Lenticule Extraction (KLEx) Versus Femtosecond Laser-assisted in Situ Keratomileusis (FS-LASIK) for the Treatment of Myopia and Compound Myopic Astigmatism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Astigmatism
Myopic Astigmatism
Keywords: KLEx
LASIK
FS-LASIK
Refractive Surgery
Astigmatism
Myopia
Lead sponsor: Instituto de Oftalmología Fundación Conde de Valenciana
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Uncorrected Visual Acuity
timeFrame: Day 1, week 1, months 1, 3, 6 & 12th after surgery.
Secondary outcomes:
measure: Postoperative spherical equivalent
timeFrame: Day 1, week 1, months 1, 3, 6 & 12th after surgery.
measure: Corrected Distance Visual Acuity
timeFrame: Day 1, week 1, months 1, 3, 6 & 12th after surgery.
measure: Loss of 2 or more lines of BCVA
timeFrame: Day 1, week 1, months 1, 3, 6 & 12th after surgery.
measure: Eyes with 0.5 Diopters within refractive target.
timeFrame: Day 1, week 1, months 1, 3, 6 & 12th after surgery.
Other outcomes:
measure: Adverse events.
timeFrame: Through study completion, an average of 1 year
Locations:
city: Mexico City
country: Mexico
facility: Instituto de Oftalmología Conde de Valenciana
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.