A Prospective Randomized Comparison of Topography-Guided LASIK Surgery to Wavefront-Guided LASIK Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percentage of eyes achieving uncorrected visual acuity
研究概览
简要总结
The study is comparing outcomes of wavefront-guided LASIK to topography-guided LASIK in a randomized contralateral fellow eye study in myopic participants.
详细描述
The purpose of the study is to compare the results of wavefront-guided LASIK surgery to topography-guided LASIK surgery in participants with nearsightedness with or without astigmatism
Three FDA-approved laser devices are being used for the study.
Two excimer lasers are being used for the study. The excimer laser is used to perform the reshaping of the cornea under a LASIK flap to correct nearsightedness, farsightedness and astigmatism. The two lasers being utilized are the Johnson and Johnson Visx CustomVue excimer laser and the Alcon Allegretto laser in the study. Both have received FDA-approval via a PMA pathway.
One femtosecond laser is being used in the study. The femtosecond laser is used to create the LASIK flap during the first part of the LASIK procedure. The Intralase iFS150 femtosecond laser is being used in the study. The femtosecond laser received FDA- approval via a 510k pathway.
All three lasers are being used according to their approved indications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 22 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects ages 22 to 59with healthy eyes. Nearsightedness between -1.00 diopters and -9.00 diopters.
- •Subjects with less than or equal to 3.00 diopters of astigmatism.
排除标准
- •Subjects under the age of 22 and over the age of 59
- •Subjects with excessively thin corneas.
- •Subjects with topographic evidence of keratoconus.
- •Subjects with ectactic eye disorders.
- •Subjects with autoimmune diseases.
- •Subjects who are pregnant or nursing.
- •Subjects must have similar levels of nearsightedness in each eye. They cannot be more than 1.5 diopter of difference between eyes.
- •Subjects with more than 3.00 diopters of astigmatism
- •Subjects must have similar levels of astigmatism in each eye. They cannot have more than 1.00 diopters of difference between eyes.
研究组 & 干预措施
Wavefront-guided LASIK
Wavefront-guided LASIK for myopia and myopic astigmatism
干预措施: Wavefront-guided LASIK (Procedure)
Topography-guided LASIK
Topography-guided LASIK for myopia and myopic astigmatism
干预措施: Wavefront-guided (Procedure)
结局指标
主要结局
Percentage of eyes achieving uncorrected visual acuity
时间窗: One year
Percentage of eyes achieving an uncorrected visual acuity of 20/40, 20/25 ,20/20, 20/16, 20/12.5 and 20/10 at post-operative month twelve
次要结局
- Percentage of eyes with a change in two or more lines of corrected visual acuity(One year)
- Patient Quality of Vision(One year)
- Predictability(One year)
- Change in corneal epithelial thickness(One year)
研究者
Edward E. Manche
Professor of Ophthalmology
Stanford University