NCT04533191已完成不适用
Binocular Custom Vision Utilizing The Light Adjustable Lens (LAL)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Binocular uncorrected distance, intermediate, and near visual acuity
研究概览
简要总结
The objective of this investigator initiated study (IIT-001) is to obtain data on clinical methods which can be used during the examination of patients desiring binocular custom vision with the Light Adjustable Lens (LAL). An analysis of the collected data will be performed to determine whether these clinical assessments can be used by doctors to enhance their patient's clinical outcome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients able to sign informed consent
- •Patients who plan to undergo bilateral implantation with the commercial LAL and receive binocular custom vision are eligible for study participation.
排除标准
- •Inability to sign informed consent
- •Any pathology for which, in the investigator's judgement, could reduce the subjects BCVA
- •Unable to return for light treatments
结局指标
主要结局
Binocular uncorrected distance, intermediate, and near visual acuity
时间窗: Through Month one post-op
Binocular uncorrected depth of focus
时间窗: Through Month one post-op
次要结局
- Manifest refraction(Through Month one post-op)
- Monocular uncorrected distance visual acuity(Through Month one post-op)
- Monocular best corrected distance visual acuity(Through Month one post-op)
- Visual Satisfaction(Through Month one post-op)
- 4th order total eye spherical aberration (Z12)(Through Month one post-op)
研究者
研究点 (1)
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