MyopiaNCT07855094
Wavelight Plus Sightmap-LASIK vs. Wavefront-Optimized-LASIK
A study testing LASIK calculated ablation using Wavefront-Optimized and wavelight plus Sightmap (WLP) Guided LASIK calculated in people with Myopia and Astigmatism, run by 59th Medical Wing at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Myopia, Astigmatism
- What is being tested?
- LASIK calculated ablation using Wavefront-Optimized and wavelight plus Sightmap (WLP) Guided LASIK calculated
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2026to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Joint Warfighter Refractive Surgery Center, JBSA Lackland AFB
San Antonio, Texas, 78236
About this study
Official title: Clinical Outcomes of Contralateral Wavelight Plus-LASIK vs. Wavefront-Optimized LASIK
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:
- Does the WLP method provide better vision than WFO method?
- Does the WLP method provide better patient satisfaction and less symptoms than WFO method?
Read more
Researchers will compare two methods for calculating LASIK customization treatment to determine which one is better.
Participants will:
- Receive LASIK in both eyes: one eye will receive WLP-LASIK and the other will receive WFO-LASIK.
- 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.
- 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.
Read the detailed description
Both WLP method and WFO method for calculating LASIK customization treatment are FDA-approved and are both performed routinely as standard of care surgery in the US Military. However, there is limited literature comparing quality of vision after WLP-LASIK and WFO-LASIK refractive surgery. Our objective is to study the 3-month visual outcomes (high and 5% low contrast visual acuity, refractive error, higher order aberrations, contrast sensitivity) and subject-reported satisfaction with vision and quality of vision (i.e., double vision, glare, starburst, halos, etc.) using the PROWL-SS questionnaire following contralateral WLP-LASIK and WFO-LASIK. This is a prospective randomized contralateral study, including 49 subjects. Once consented to participate in the study, subjects will have a comprehensive ocular examination to determine eligibility to undergo simultaneous WLP-LASIK surgery in one eye and WFO-LASIK on the contralateral eye to correct myopia. Surgical treatment will be randomized so there is a 50% chance to receive WLP-LASIK on the right eye and WFO-LASIK on the contralateral eye. Subjects will receive standard of care topical ophthalmic antibiotic and steroid drops. Visual outcomes and patient self-reported symptoms will be assessed at day 1, week 1, month 1, and month 3.
- Conditions
- Myopia, Astigmatism
- Being tested
- LASIK calculated ablation using Wavefront-Optimized, wavelight plus Sightmap (WLP) Guided LASIK calculated
- Keywords
- Ray-tracing, LASIK, wavefront-optimized, wavelight plus SightMap
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LASIK calculated ablation using Wavefront-OptimizedProcedure or surgery
WFO LASIK
wavelight plus Sightmap (WLP) Guided LASIK calculatedProcedure or surgery
WLP Sightmap
| Study group | Role | What they receive |
|---|---|---|
| wavelight plus SightMap-guided LASIK (WLP-LASIK) | Experimental | Eye having LASIK Surgery guided by Wavelight Plus SightMap (WLP) Receives: Procedure: wavelight plus Sightmap (WLP) Guided LASIK calculated |
| Wavefront-Optimized LASIK (WFO-LASIK) | Active comparator | Eye having Wavefront-Optimized LASIK eye surgery Receives: Procedure: LASIK calculated ablation using Wavefront-Optimized |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3-months Post-Op
Secondary outcomes (1)
Percentage of eyes with Uncorrected Visual Acuity of 20/16 or better at 3-month Post-Op
Post-operative uncorrected visual acuity of 20/16 or better measure with ETDRS chart; unit = percentage eyes
Measured: 3-month Post-Op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start6 Jan 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized contralateral study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 59th Medical Wing
- Sponsor type
- US federal agency
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
- Investigators
- Paramjit K Bhullar, MD, Principal investigator, 59th Medical Wing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855094
- Sponsor's protocol ID
- C.2026.011
- Other IDs
- FWH20260014H
- Status last verified
- Jan 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40482723Cao 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.
PubMed 39656251Kanellopoulos 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.
PubMed 38410630