Wavelight Plus Sightmap-LASIK vs. Wavefront-Optimized-LASIK
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?
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Texas
-
San Antonio, Texas, Yhdysvallat, 78236
- Joint Warfighter Refractive Surgery Center, JBSA Lackland AFB
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: wavelight plus SightMap-guided LASIK (WLP-LASIK)
Eye having LASIK Surgery guided by Wavelight Plus SightMap (WLP) |
WLP Sightmap |
|
Active Comparator: Wavefront-Optimized LASIK (WFO-LASIK)
Eye having Wavefront-Optimized LASIK eye surgery |
WFO LASIK |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Percentage of eyes achieving MRSE within ±0.25D at 3-month Post-Op
Aikaikkuna: 3-months Post-Op
|
Post-operative manifest refraction spherical equivalent (MRSE) within ±0.25D at POM3; unit = percentage of eyes |
3-months Post-Op
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Percentage of eyes with Uncorrected Visual Acuity of 20/16 or better at 3-month Post-Op
Aikaikkuna: 3-month Post-Op
|
Post-operative uncorrected visual acuity of 20/16 or better measure with ETDRS chart; unit = percentage eyes |
3-month Post-Op
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in high contrast visual acuity at 3-month Post-Op
Aikaikkuna: Change from baseline (pre-op) to 3-month Post-Op
|
Change in the mean uncorrected visual acuity (unit = logMAR) measure with ETDRS chart from baseline (pre-op) at 3 months Post-Op |
Change from baseline (pre-op) to 3-month Post-Op
|
|
Change in refractive error at 3-month Post-Op
Aikaikkuna: Change from baseline (pre-op) to 3-month Post-Op
|
Change in the mean refractive error measure with phoropter (unit = diopters) from baseline (pre-op) at 3 months Post-Op |
Change from baseline (pre-op) to 3-month Post-Op
|
|
Change in low contrast visual acuity at 3-month Post-Op
Aikaikkuna: Change from baseline (pre-op) to 3-month Post-Op
|
Change in the mean low contrast visual acuity (unit = logMAR) measure with ETDRS 5% chart from baseline (pre-op) at 3 months Post-Op |
Change from baseline (pre-op) to 3-month Post-Op
|
|
Change in Contrast Sensitivity at 3-month Post-Op
Aikaikkuna: Change from baseline (pre-op) to 3-month Post-Op
|
Change in Contrast Sensitivity (unit = cpm) measure with CSV-1000 tester under dim (mesopic) and bright light (photopic) conditions from baseline (pre-op) at 3 months Post-Op |
Change from baseline (pre-op) to 3-month Post-Op
|
|
Change in higher order aberrations at 3-month Post-Op
Aikaikkuna: Change from baseline (pre-op) to 3-month Post-Op
|
Change in the mean higher order aberrations (unit = root mean square) measure with Wavelight Plus SightMap from baseline (pre-op) at 3 months Post-Op |
Change from baseline (pre-op) to 3-month Post-Op
|
|
Change in mean score Patient-Reported Outcomes with LASIK Symptoms and Satisfaction (PROWL-SS) Questionnaire at 3-month Post-Op
Aikaikkuna: Change from baseline (pre-op) to 3-month Post-Op
|
The PROWL-SS is a validated tool to assess self-reported symptoms and satisfaction after refractive surgery. Possible Satisfaction Score ranges from 1 (completely satisfied) to 6 (completely dissatisfied). Lower value indicates higher satisfaction. Possible Symptoms Score ranges from 1 (extremely bothersome) to 5 (not at all bothersome). Lower value indicates worse symptoms. |
Change from baseline (pre-op) to 3-month Post-Op
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Paramjit K Bhullar, MD, 59th Medical Wing
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
- 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.
- 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.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- C.2026.011
- FWH20260014H (Muu tunniste: 59th HRPP)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Yhdysvalloissa valmistettu ja sieltä viety tuote
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