- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04919291
Direct Comparison of TG and WFO LASIK
Contralateral Comparison of Togoguided LASIK and Wavefront-optimized LASIK
To compare the efficacy to different profiles, direct head-to-head studies had been conducted. In one previous review study revealed that TG LASIK provided patient with better uncorrected visual acuity (UCVA) than WFO LASIK and WFG LASIK. In recent previous contralateral eye studies also showed that TG LASIK induced less postoperative higher-order aberration than WFO LASIK. However, these studies included only low-to-moderate myopia patients, for patients with high myopia (spherical equivalent > 6D), the effect of TG LASIK comparing with WFO LASIK had not been reported before.
The aim of our study is to analyze and compare the visual performance of TG LASIK and WFO LASIK in high myopia and low-to-moderate myopia patients, , particularly UCVA, corrected distance visual acuity (CDVA), contrast sensitivity (CS), and wavefront aberration.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Taipei, 대만
- Taipei Nobel Eye Clinic
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- age between 20 and 50 years old
- CDVA of both eyes could reach 0.1 logarithm of the minimum angle of resolution (logMAR)
- stable refractive errors of myopia and astigmatism
Exclusion Criteria:
- cataract
- corneal opacities or irregularities
- dry eye (Schirmer's test I ≤ 5mm)
- amblyopia
- coexisting ocular pathologies
- glaucoma
- non-dilating pupil
- history of intraocular surgery, laser therapy, or retinopathy
- optic nerve or macular diseases
- estimated postoperative cornea residual stromal thickness less than 250 μm
- pregnancy or under lactation
- uncontrolled diabetic mellitus or systemic immune disease
- refusal or unable to maintain follow-up
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Topoguided LASIK
Topoguided ablation profile on dominant eye
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Topoguided ablation profile on dominant eye
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활성 비교기: Wavefront optimized LASIK
Wavefront optimized ablation profile on non-dominant eye
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Wavefront optimized ablation profile on non-dominant eye
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Visual acuity
기간: 3 months after surgery
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uncorrected visual acuity and corrected distance visual acuity
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3 months after surgery
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Corneal wavefront analysis
기간: 3-months postoperative visit
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horizontal coma aberration (Z 3,1), spherical aberration (Z 4,0), and trefoil aberration
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3-months postoperative visit
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Contrast sensitivity
기간: 3-months postoperative visit
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4 spatial frequencies: 3, 6, 12, and 18 cycles per degree (cpd).
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3-months postoperative visit
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Quality of vision questionnaire
기간: 3-months postoperative visit
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A 11-item questionnaire, item scores range from 0 to 10 and higher item scores in questionnaire indicated more difficulty in achieving specific visual tasks
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3-months postoperative visit
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Sutton G, Lawless M, Hodge C. Laser in situ keratomileusis in 2012: a review. Clin Exp Optom. 2014 Jan;97(1):18-29. doi: 10.1111/cxo.12075. Epub 2013 Jun 21. Review.
- Moreno-Barriuso E, Lloves JM, Marcos S, Navarro R, Llorente L, Barbero S. Ocular aberrations before and after myopic corneal refractive surgery: LASIK-induced changes measured with laser ray tracing. Invest Ophthalmol Vis Sci. 2001 May;42(6):1396-403.
- Schallhorn SC, Farjo AA, Huang D, Boxer Wachler BS, Trattler WB, Tanzer DJ, Majmudar PA, Sugar A; American Academy of Ophthalmology. Wavefront-guided LASIK for the correction of primary myopia and astigmatism a report by the American Academy of Ophthalmology. Ophthalmology. 2008 Jul;115(7):1249-61. doi: 10.1016/j.ophtha.2008.04.010.
- Stonecipher K, Parrish J, Stonecipher M. Comparing wavefront-optimized, wavefront-guided and topography-guided laser vision correction: clinical outcomes using an objective decision tree. Curr Opin Ophthalmol. 2018 Jul;29(4):277-285. doi: 10.1097/ICU.0000000000000495. Review.
- Kim J, Choi SH, Lim DH, Yang CM, Yoon GJ, Chung TY. Topography-guided versus wavefront-optimized laser in situ keratomileusis for myopia: Surgical outcomes. J Cataract Refract Surg. 2019 Jul;45(7):959-965. doi: 10.1016/j.jcrs.2019.01.031. Epub 2019 Jun 10.
- Kim J, Choi SH, Lim DH, Yoon GJ, Chung TY. Comparison of outcomes after topography-modified refraction versus wavefront-optimized versus manifest topography-guided LASIK. BMC Ophthalmol. 2020 May 14;20(1):192. doi: 10.1186/s12886-020-01459-0. Erratum in: BMC Ophthalmol. 2020 Dec 29;20(1):492.
- Ozulken K, Yuksel E, Tekin K, Kiziltoprak H, Aydogan S. Comparison of Wavefront-Optimized Ablation and Topography-Guided Contoura Ablation With LYRA Protocol in LASIK. J Refract Surg. 2019 Apr 1;35(4):222-229. doi: 10.3928/1081597X-20190304-02.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
각막절삭술, 레이저 인 시튜에 대한 임상 시험
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Vissum, Instituto Oftalmológico de Alicante완전한LASIK-Laser in Situ Keratomileusis 후 안구건조증
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University Hospital, Brest모병
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Istanbul University완전한
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Singapore National Eye CentreSingapore Armed Forces; Defence Medical Environmental Research Institute완전한