Clinical Evaluation of Visual Outcomes in LEAP, HIGH, COMP and VISN Extension Cohort
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Distance-corrected intermediate visual acuity
研究概览
简要总结
This is a prospective, multicenter, parallel groups, non-interventional, examiner masked, comparative clinical study. Patients that participated in previous Hoya studies, and patients previous implanted with Hoya non-toric monofocal IOLs (sub-study only) will be enrolled in the study. The sample size for this study is based on demonstrating the non-inferiority of the mean distance-corrected intermediate visual acuity (DCIVA) in Group 1 (Site 1) compared with Group 2 (Site 2).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Main study:
- •Previously implanted with intraocular lens through 2 previous IOL studies;
- •Clear intraocular media with no clinically significant opacity, in the investigator's judgment, that would affect visual acuity;
- •Able to provide informed consent and complete all required study procedures.
- •Exploratory sub-study:
- •1. Additional inclusion criteria: Pseudophakic eyes implanted with one of the IOLs in one eye from 3 previous IOL studies
排除标准
- •Main study:
- •Corrected distance visual acuity (CDVA) worse than 0.2 logMAR (or 20/32 Snellen)
- •Subjects with ongoing medical conditions or treatment that might impact outcomes during the study visit as determined by the investigator.
- •Exploratory sub-study:
- •1. Additional exclusion criteria: Pseudophakic eyes with oblique residual astigmatism.
研究组 & 干预措施
Subjects to participate in main study only
Evaluate visual outcomes in extension cohort
干预措施: Non-Interventional Study (Other)
Subjects to participate in exploratory sub-study only
Evaluate visual outcomes in extension cohort
干预措施: Non-Interventional Study (Other)
Subjects to participate in both main and sub-study
Evaluate visual outcomes in extension cohort
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Distance-corrected intermediate visual acuity
时间窗: Up to 15 days
The primary objective of this study is to evaluate whether visual performance in eyes from Group 1 (Site 1) is non-inferior to eyes from Group 2 (Site 2) with respect to distance-corrected intermediate visual acuity (DCIVA), using a predefined non-inferiority margin of 0.10 logMAR.
次要结局
- Corrected distance visual acuity and distance-corrected near acuity(Up to 15 days)