A Prospective Eye to Eye Comparison of LASIK Using the Alcon Allegretto Wavefront-Guided Excimer Laser Versus AMO Visx Wavefront-Guided Excimer Laser
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Efficacy
研究概览
简要总结
The purpose of the study is to compare the results of LASIK surgery when using Alcon Allegretto wavefront-guided excimer laser system compared to AMO Visx Custom wavefront-guided excimer laser system in patients with nearsightedness with and without astigmatism.
详细描述
The patients will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. if there is any pathology noted that would exclude the patient from the study, then we will inform the patient and make an appropriate referral. If the patient is deemed appropriate for the study after a comprehensive examination included computerized videokeratography, then they can be enrolled. The patient will undergo bilateral simultaneous eye surgery. Which eye is treated with a wavefront-guided excimer laser and which eye is treated with wavefront-optimized will be randomized so there is a 50% chance for either eye to receive one treatment. The patients will be seen on the day of surgery, post op day one, post op day 4-7, one month, three months, six months and one year. The patient will receive topical antibiotics in each eye for one week following the procedure. LASIK treated eyes will receive pred forte 1% ophthalmic drops for one week after treatment. All of this is within the usual and customary standard of care for the treatment of patients undergoing lasik surgery.
The research procedures are the least risky that can be performed consistent with sound research design.
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
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects age 21 and older with healthy eyes.
- •Nearsightedness between -0.50 diopters and -7.00 diopters with or without astigmatism of up to 3.50 diopters.
排除标准
- •Subjects under the age of
- •Patients with excessively thin corneas.
- •Patients with topographic evidence of keratoconus.
- •Patients with ectatic eye disorders.
- •Patients with autoimmune diseases.
- •Patients who are pregnant or nursing.
- •Patients must have similar levels of nearsightedness with or without astigmatism in each eye.
- •They can not be more than 1.5 diopters of difference between eyes.
- •Patients must have similar levels of astigmatism in each eye.
- •They can not have more than 1.5 diopters of difference in nearsightedness or astigmatism between their two eyes.
结局指标
主要结局
Efficacy
时间窗: 1 year
Efficacy measures uncorrected visual acuity following the LASIK surgery. We will record how many eyes see 20/40, 20/30, 20/25, 20/20, 20/16, 20/12.5 and 20/10 after the surgery without glasses or contact lenses. We are measuring how well patients see after the surgery without glasses or contact lenses.
次要结局
- Safety(One year)
- Predictability(One year)
- Low contrast visual acuity(1 year)
- Higher order aberrations(1 year)
研究者
Edward E. Manche
Professor of Ophthalmology
Stanford University