Compare the Safety and Effectiveness of Two Versions of the Bausch & Lomb Zyoptix™ Tissue Saving Aspheric Algorithm to the Current Zyoptix™ Tissue Saving Algorithm When Used for Myopia and Myopic Astigmatism Lasik Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 主要终点
- Uncorrected visual acuity
研究概览
简要总结
The objective of this study was to compare the safety and effectiveness of two versions of the Bausch & Lomb Zyoptix Tissue Saving Aspheric Algorithm versus the current Zyoptix Tissue Saving Algorithm when used for myopia and myopic astigmatism LASIK 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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Myopia with or without astigmatism.
- •Normal Corneal topography
- •Willing to have both eyes treated with the laser.
排除标准
- •Contraindications to LASIK.
研究组 & 干预措施
Zyoptix Tissue Saving Aspheric
The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithm is used for treatment with LASIK for the correction of myopia and myopic astigmatism.
干预措施: The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithm (Device)
Zyoptix Tissue Saving
The Bausch & Lomb Zyoptix Tissue Saving algorithm is used for treatment with LASIK for the correction of myopia and myopic astigmatism.
干预措施: The Bausch & Lomb Zyoptix Tissue Saving algorithm (Device)
结局指标
主要结局
Uncorrected visual acuity
时间窗: At 90 days post surgery
Preservation of best spectacle corrected high contrast logMAR distance visual acuity compared to baseline.
时间窗: At 90 days post surgery
次要结局
- Deviation from target correction(At 90 days post surgery)
- Improvement in uncorrected distance high contrast logMAR visual acuity compared to baseline(At 90 days post surgery)