Ignite Creation Date:
2024-07-17 @ 11:04 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06477081
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-17
Brief Title:
KLEx Versus FS-LASIK for the Treatment of Myopia and Compound Myopic Astigmatism
Sponsor:
Instituto de Oftalmología Fundación Conde de Valenciana
Organization:
Instituto de Oftalmología Fundación Conde de Valenciana
Study Overview
Official Title:
Keratorefractive Lenticule Extraction KLEx Versus Femtosecond Laser-assisted in Situ Keratomileusis FS-LASIK for the Treatment of Myopia and Compound Myopic Astigmatism
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 05 diopters of the intended target Secondary outcome parameters include quality vision measurements refraction visual acuity and adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None