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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Texas
-
San Antonio, Texas, 미국, 78236
- Joint Warfighter Refractive Surgery Center, JBSA Lackland AFB
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-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: wavelight plus SightMap-guided LASIK (WLP-LASIK)
Eye having LASIK Surgery guided by Wavelight Plus SightMap (WLP) |
WLP Sightmap |
|
활성 비교기: Wavefront-Optimized LASIK (WFO-LASIK)
Eye having Wavefront-Optimized LASIK eye surgery |
WFO LASIK |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of eyes achieving MRSE within ±0.25D at 3-month Post-Op
기간: 3-months Post-Op
|
Post-operative manifest refraction spherical equivalent (MRSE) within ±0.25D at POM3; unit = percentage of eyes |
3-months Post-Op
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of eyes with Uncorrected Visual Acuity of 20/16 or better at 3-month Post-Op
기간: 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
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in high contrast visual acuity at 3-month Post-Op
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Paramjit K Bhullar, MD, 59th Medical Wing
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- C.2026.011
- FWH20260014H (기타 식별자: 59th HRPP)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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