70 Versus 110 Degrees Side-cut Angles in Femtosecond Laser-assisted in Situ Keratomileusis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Uncorrected Visual Acuity at One Year
研究概览
简要总结
The purpose of this study is to compare 70 and 110 degree side-cut angles on the same patient undergoing Femtosecond Laser-assisted in Situ Keratomileusis (FS-LASIK).
详细描述
LASIK has become the preferred corneal procedure to correct certain refractive errors. One of the major advancements in LASIK has been the introduction of Femtosecond Laser technology for flap creation. Several studies have compared microkeratome and femtosecond laser technology, showing superior accuracy and precision of flap dimensions in the latter.
The Femtosecond Laser technology provides different parameters and settings that can be changed according to the surgeon's preference. One of such parameters is the side-cut angle. Some of the most common side-cut angles used today include 45, 70, 90, and 110 degrees. Previous studies have reported on the visual outcomes of side-cut angles, but head to head comparisons are lacking. Currently, there are no studies comparing the safety and efficacy of the 70 and 110 side-cut angles in FS-LASIK. Information regarding the outcomes and complication rates between these side-cut angles will provide an objective measure that can be used when deciding which one is more suitable in FS-LASIK.
One angle will be performed on the right eye and the other on the left eye. The study will evaluate uncorrected visual acuity, best corrected visual acuity, intraoperative, and postoperative complications. Performing different side-cut angles on the same individual will allow a direct comparison of outcomes, minimizing confounding variables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Each participant will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow 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
- •Subjects who are deemed suitable candidates for bilateral LASIK will be considered eligible for participation in this study. Correction will be distance for both eyes.
排除标准
- •Selection will be consistent with current standard of care. Any patient that is not a suitable candidate for LASIK will not be included.
研究组 & 干预措施
FS-LASIK 70 degree side-cut angle
Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.
干预措施: FS-LASIK 70 degree side-cut angle (Device)
FS-LASIK 70 degree side-cut angle
Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.
干预措施: FS-LASIK 110 degree side-cut angle (Device)
FS-LASIK 110 degree side-cut angle
Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.
干预措施: FS-LASIK 70 degree side-cut angle (Device)
FS-LASIK 110 degree side-cut angle
Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.
干预措施: FS-LASIK 110 degree side-cut angle (Device)
结局指标
主要结局
Uncorrected Visual Acuity at One Year
时间窗: one year
Vision testing without correction, both eyes using Snellen Eye chart
次要结局
- Best Corrected Visual Acuity at Year One(one year)
研究者
Mark Mifflin
Clinical Professor, Ophthalmology/Visual Sciences
University of Utah