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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Taipei、台湾
- Taipei Nobel Eye Clinic
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:Topoguided LASIK
Topoguided ablation profile on dominant eye
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Topoguided ablation profile on dominant eye
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有源比较器: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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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Visual acuity
大体时间: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
大体时间: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
大体时间: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
大体时间: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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合作者和调查者
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Topoguided LASIK的临床试验
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Walter Reed Army Medical Center完全的
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Bismarck LasikSengi终止
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Moorfields Eye Hospital NHS Foundation Trust完全的