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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Texas
-
San Antonio、Texas、アメリカ、78236
- Joint Warfighter Refractive Surgery Center, JBSA Lackland AFB
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：wavelight plus SightMap-guided LASIK (WLP-LASIK)
Eye having LASIK Surgery guided by Wavelight Plus SightMap (WLP) |
WLP Sightmap |
|
アクティブコンパレータ：Wavefront-Optimized LASIK (WFO-LASIK)
Eye having Wavefront-Optimized LASIK eye surgery |
WFO LASIK |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of eyes achieving MRSE within ±0.25D at 3-month Post-Op
時間枠：3-months Post-Op
|
Post-operative manifest refraction spherical equivalent (MRSE) within ±0.25D at POM3; unit = percentage of eyes |
3-months Post-Op
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of eyes with Uncorrected Visual Acuity of 20/16 or better at 3-month Post-Op
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in high contrast visual acuity at 3-month Post-Op
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- C.2026.011
- FWH20260014H (その他の識別子：59th HRPP)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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