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ACTIVE NOT RECRUITING

NCT07855094

Wavelight Plus Sightmap-LASIK vs. Wavefront-Optimized-LASIK

Sponsor: 59th Medical Wing

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if the wavelight plus Sightmap (WLP) method or the wavefront-optimized (WFO) method for calculating LASIK customization treatment gives better vision, better satisfaction, and fewer symptoms afterward. The main questions it aims to answer are: 1. Does the WLP method provide better vision than WFO method? 2. Does the WLP method provide better patient satisfaction and less symptoms than WFO method? Researchers will compare two methods for calculating LASIK customization treatment to determine which one is better. Participants will: 1. Receive LASIK in both eyes: one eye will receive WLP-LASIK and the other will receive WFO-LASIK. 2. Be in the study for about three months and will have six clinic visits: a pre-op qualification exam, the surgery visit, and follow-up visits on 1 day, 1 week, 1 month, and 3 months after surgery. 3. Have several eye test to assess vision and complete a symptom questionnaire. This questionnaire will take approximately ten (10) minutes to complete in person during.

Official title: Clinical Outcomes of Contralateral Wavelight Plus-LASIK vs. Wavefront-Optimized LASIK

Key Details

Gender

All

Age Range

21 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-01-06

Completion Date

2026-12-31

Last Updated

2026-10-02

Healthy Volunteers

Conditions

Myopia Astigmatism

Interventions

PROCEDURE

LASIK calculated ablation using Wavefront-Optimized

WFO LASIK

PROCEDURE

wavelight plus Sightmap (WLP) Guided LASIK calculated

WLP Sightmap

Inclusion Criteria: * Male and Females between the ages of 21 and 50 * Monocular CDVA of 20/20 or better * Nearsightedness between -2.00 diopters and -8.00 diopters * Have similar levels of nearsightedness in each eye (≤2D of difference between eyes) * Total spherical equivalent (SE) of no more than -9.0 D * Less than or equal to 3.00 diopters of astigmatism * Stable refraction (within ±0.50 D) as determined by MRSE for a minimum of 12 months prior to surgery * ≤0.50 D MRSE difference between cycloplegic and subjective manifest refractions * Active duty and Beneficiary on Tricare Prime or Tricare Select * Residing within 60 miles radius from Lackland AFB * Willing and able to attend all scheduled study visits as required per protocol Exclusion Criteria: * Subjects with corneal abnormal findings including signs of keratoconus, keratoconus suspect, abnormal corneal topography, epithelial basement membrane disease, pellucid marginal degeneration, corneal degenerations, recurrent corneal erosion, progressive and unstable myopia, irregular or unstable corneal mires on central keratometry images, and subjects whose corneal thickness would cause anticipated treatment would violate the posterior 250 microns (μm) of corneal stroma from the corneal endothelium. * Subjects with any ocular disease such as advanced/uncontrolled glaucoma, strabismus, severe dry eye, active eye infection or inflammation, recent herpes eye infection or problems resulting from past infection, or having a cardiac pacemaker/implanted defibrillator. * Subjects with active collagen vascular, connective tissue, autoimmune or immunodeficiency diseases * Pregnant or nursing females (pregnancy test will be performed on females subjects of childbearing potential) * Systemic disease likely to affect wound healing, such as diabetes and severe atopy, severe allergies * Taking the medication Isotretinoin (Accutane), Amiodarone hydrochloride (Cordaroneor), Sumatriptan succinate (Imitrex), antimetabolites for any medical condition * Potential candidate who cannot provide Informed Consent will not be allowed to participate

Locations (1)

Joint Warfighter Refractive Surgery Center, JBSA Lackland AFB

San Antonio, Texas, United States