Outcomes of Topography-guided LASIK and Photorefractive Keratectomy Compared to Wavefront Optimized LASIK and Photorefractive Keratectomy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Change in Uncorrected Visual Acuity From Baseline to Month 12
研究概览
简要总结
This study evaluates the difference in results between eyes that have been treated wavefront optimized laser vision correction (either LASIK or Photorefractive Keratectomy) compared to eyes treated with topography-guided laser vision correction (either LASIK or Photorefractive Keratectomy). Each participant will receive wavefront optimized correction in one eye and topography-guided correction in the other.
详细描述
Participants will have an in depth discussion with our refractive surgery coordinator regarding refractive surgery. Patients will choose LASIK or Photorefractive Keratectomy surgery based on our standard pre-operative discussion that is provided to all patients. As is standard for laser refractive candidates, the advantages and disadvantages of LASIK and Photorefractive Keratectomy compared to the other refractive surgical options will be discussed. Following patient selection of their preferred type of refractive procedure they will be randomized as discussed below, and only patients who elect for LASIK or Photorefractive Keratectomy will be included in our study.
Prior to surgery, one eye from each patient will be randomly assigned to receive either Wavefront optimized or Topography Guided treatment. Each patient in the study will have a fellow eye enrolled in the other treatment group. Patients will either receive LASIK treatment or Photorefractive Keratectomy treatment in both eyes but the eyes will be randomized to topography guided or wavefront optimized forms of treatment.
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)
盲法说明
Participants will be masked as to which type of surgery they receive in either eye.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects who are deemed suitable candidates for laser refractive surgery after routine refractive surgery screening will be considered eligible for participation in this study.
- •Subjects must be at least 21 years of age and not pregnant or nursing (due to fluctuations in visual parameters during pregnancy)
排除标准
- •Any patient who is not a suitable candidate for LASIK or PRK will not be included.
结局指标
主要结局
Change in Uncorrected Visual Acuity From Baseline to Month 12
时间窗: 12 months
Uncorrected visual acuity will be tested pre-operatively through month 12
次要结局
- Change in Contrast Sensitivity From Baseline to Month 3(3 months)
研究者
Mark Mifflin
Professor, Ophthalmology/Visual Sciences
University of Utah