Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 245
- 试验地点
- 18
- 主要终点
- Monocular photopic DCIVA (first eyes) at 66 cm
研究概览
简要总结
Prospective, multicenter, bilateral, interventional, controlled, masked (sponsor, subjects, and evaluators), randomized clinical trial.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be considered for enrollment in this study, patient must:
- •be at least 22 years old
- •have cataracts in both eyes
- •sign the written informed consent
- •be willing and able to comply with examination procedures
- •understand, read and write English to complete informed consent and questionnaires
- •be available for study follow-up visits
排除标准
- •Patient will not be eligible to take part in the study if:
- •currently participating in any other clinical study or have participated in a clinical study during the last 30 days
- •have a certain disease/illness, such as poorly controlled diabetes
- •have certain ocular conditions, such as uncontrolled pressure in the eye
- •taking medication that may affect vision
- •pregnant, plan to become pregnant during the study, or are breastfeeding
研究组 & 干预措施
Test IOL
DEN00V
干预措施: Test IOL Model DEN00V (Device)
Control IOL
DCB00
干预措施: Control IOL Model DCB00 (Device)
结局指标
主要结局
Monocular photopic DCIVA (first eyes) at 66 cm
时间窗: 6 months
Mean DCIVA (logMAR) in test lens group is statistically significantly better (smaller) than in the control lens group
Monocular Depth of Focus
时间窗: 6 months
Monocular depth of defocus where visual acuity is 0.20 logMAR or better (measured only negative direction from zero) for first eyes at 6 months
Monocular Photopic DCVA at 100 cm
时间窗: 6 months
Monocular photopic DCVA at 100 cm for first eyes at 6 months
Monocular Photopic BCDVA at 4m
时间窗: 6 months
Monocular photopic BCDVA at 4 meters for first eyes at 6 months
Monocular (First Eyes) Photopic DCIVA at 66 cm
时间窗: 6 months
Monocular photopic distance-corrected intermediate visual acuity (DCIVA) in logMAR at 66 cm for first eyes. Note that a lower logMAR value denotes better visual acuity. The difference in mean visual acuity is calculated as control group minus test group. This analysis was prespecified for the first operative eye.
Monocular (First Eyes) Depth of Focus
时间窗: 6 months
Monocular depth of defocus where visual acuity is 0.20 logMAR or better (measured only negative direction from zero diopter) for first eyes. The data values reported represent the diopter of defocus at which the mean visual acuity for all participants crosses the 0.20 logMAR threshold. Therefore, the values reported are represented as a single value for each arm. This analysis was prespecified for the first operative eye.
Monocular (First Eyes) Photopic BCDVA at 4m
时间窗: 6 months
Monocular photopic best-corrected distance visual acuity (BCDVA) in logMAR at 4 meters for the first eyes. Note that a lower logMAR value denotes better visual acuity. The difference in mean visual acuity is calculated as control group minus test group. This analysis was prespecified for the first operative eye.
Monocular (First Eyes) Photopic DCVA at 100 cm
时间窗: 6 months
Monocular photopic Distance Corrected Visual Acuity (DCVA) in logMAR at 100 cm for first eyes. This analysis was prespecified for the first operative eye.
次要结局
- Monocular photopic DCNVA at 40 cm (first eyes)(6 months)