A Prospective Randomized Comparison of Wavefront-guided LASIK Surgery to Ray Tracing-Guided LASIK Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Uncorrected visual acuity
研究概览
简要总结
We are enrolling participants aged 22 and older to have LASIK surgery in both eyes. We will perform wavefront-guided LASIK in one eye and ray tracing-guided LASIK in the fellow eye of each participant. We are trying to see if there are any differences in the efficacy between the two types of LASIK procedures.
详细描述
We are comparing the outcomes of wavefront-guided LASIK (laser in-situ keratomileusis) and ray tracing-guided LASIK for nearsightedness with and without astigmatism.
Wavefront aberrometry (a non-contact laser measuring device) is an automated device that measures the refractive status of the eye. This data is then transferred to the laser system and calculates a unique treatment to reduce or eliminate your nearsightedness with and without astigmatism (a non-spherical shape).
One eye will be treated with ray tracing-guided LASIK and the other eye treated with the wavefront-guided LASIK. Each participant will receive both wavefront-guided LASIK and ray-tracing guided LASIK. Both wavefront-guided LASIK and ray tracing-guided LASIK are FDA-approved procedures. Both procedures are being performed according to the FDA-approved labeling.
We plan to enroll up to 70 near-sighted study participants to undergo treatment in this clinical research trial.
The choice of which eye receives ray tracing-guided LASIK surgery and which eye receives wavefront-guided LASIK will be randomized (assigned at random) prior to enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age 22 and older
- •People with healthy eyes:
- •No abnormal corneal shape
- •No excessively thin corneas
- •No eye diseases such as glaucoma or cataracts
- •Nearsightedness between -1.00 diopters and -10.00 diopters.
- •Subjects with less than or equal to 3.00 diopters of astigmatism.
- •Subjects must have similar levels of nearsightedness in each eye.
排除标准
- •Subjects under the age of
- •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 at the time of surgery. (The FDA-approved labelling indications for LASIK specifically excludes patients who are pregnant or nursing. There is no strict prohibition not to become pregnant during the one year study period)
- •They can not be more than 1.5 diopter of difference between eyes.
- •Subjects with more than 3.00 diopters of astigmatism
- •Subjects with disimilar levels of astigmatism in each eye (They can not have more than 0.75 diopters of difference between eyes) -
结局指标
主要结局
Uncorrected visual acuity
时间窗: One year
Uncorrected visual acuity using ETDRS charts
次要结局
- 5 and 25% best corrected low contrast visual acuity(12 months)
- Achieved versus attempted ablation depth measured by anterior segment OCT(One, three and twelve months)
- Self reported quality of vision and quality of life measures(Three, six and twelve months)
研究者
Edward E. Manche
Professor of Ophthalmology
Stanford University