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

NCT07855094 | Active Not Recruiting

• 2 other identifiers: C.2026.011FWH20260014H
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does the WLP method provide better vision than WFO method?
2. 2.Does the WLP method provide better patient satisfaction and less symptoms than WFO method?
3. 3.Receive LASIK in both eyes: one eye will receive WLP-LASIK and the other will receive WFO-LASIK.
4. 4.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.
5. 5.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.

Conditions

Myopia; Astigmatism

Keywords

Ray-tracing; LASIK; wavefront-optimized; wavelight plus SightMap

Outcome Measures

Primary Outcomes (1)

• Percentage of eyes achieving MRSE within ±0.25D at 3-month Post-Op

  Post-operative manifest refraction spherical equivalent (MRSE) within ±0.25D at POM3; unit = percentage of eyes

  3-months Post-Op

Secondary Outcomes (1)

• Percentage of eyes with Uncorrected Visual Acuity of 20/16 or better at 3-month Post-Op

  3-month Post-Op

Other Outcomes (6)

• Change in high contrast visual acuity at 3-month Post-Op

  Change from baseline (pre-op) to 3-month Post-Op

• Change in refractive error at 3-month Post-Op

  Change from baseline (pre-op) to 3-month Post-Op

• Change in low contrast visual acuity at 3-month Post-Op

  Change from baseline (pre-op) to 3-month Post-Op

Study Arms (2)

wavelight plus SightMap-guided LASIK (WLP-LASIK)

EXPERIMENTAL

Eye having LASIK Surgery guided by Wavelight Plus SightMap (WLP)

Procedure: wavelight plus Sightmap (WLP) Guided LASIK calculated

Wavefront-Optimized LASIK (WFO-LASIK)

ACTIVE COMPARATOR

Eye having Wavefront-Optimized LASIK eye surgery

Procedure: LASIK calculated ablation using Wavefront-Optimized

Interventions

LASIK calculated ablation using Wavefront-Optimized PROCEDURE

WFO LASIK

Wavefront-Optimized LASIK (WFO-LASIK)

wavelight plus Sightmap (WLP) Guided LASIK calculated PROCEDURE

WLP Sightmap

wavelight plus SightMap-guided LASIK (WLP-LASIK)

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• 59th Medical Wing: lead
• Alcon Research: collaborator

Study Sites (1)

Joint Warfighter Refractive Surgery Center, JBSA Lackland AFB

San Antonio, Texas, 78236, United States

Location

Related Publications (3)

• Khoramnia R, Naujokaitis T, Block L, Fabian K, Kessler LJ, Labuz G, Auffarth GU. Prospective Intraindividual Comparison of Automated Customized Ray-Tracing-Guided versus Wavefront-Optimized LASIK. Ophthalmology. 2025 Oct;132(10):1169-1179. doi: 10.1016/j.ophtha.2025.05.025. Epub 2025 Jun 5.

  PMID: 40482723 BACKGROUND

• Cao X, Zhang J, Shao J, Zhang Y, Zheng L. Study of the InnovEyes Sightmap Platform in Comparing Ray-Tracing-Guided LASIK and Topography-Guided LASIK. J Refract Surg. 2024 Dec;40(12):e994-e1002. doi: 10.3928/1081597X-20241030-03. Epub 2024 Dec 1.

  PMID: 39656251 BACKGROUND

• Kanellopoulos AJ. Ray-Tracing Customization in Myopic and Myopic Astigmatism LASIK Treatments for Low and High Order Aberrations Treatment: 2-Year Visual Function and Psychometric Value Outcomes of a Consecutive Case Series. Clin Ophthalmol. 2024 Feb 22;18:565-574. doi: 10.2147/OPTH.S444174. eCollection 2024.

  PMID: 38410630 BACKGROUND

MeSH Terms

Conditions

Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Paramjit K Bhullar, MD

  59th Medical Wing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is a prospective randomized double blind contralateral study. The patient and the staff doing the post-op evaluations will be blinded to which eye received which treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Prospective randomized contralateral study.

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start: January 6, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)