A Prospective, Randomized, Controlled, Multi-Center Clinical Investigation of the AcrySof IQ Vivity Extended Vision IOL vs. TECNIS Symfony and AT LARA Extended Depth of Focus IOLs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 222
- 试验地点
- 23
- 主要终点
- Percentage of Subjects Not Bothered at All by Halos (QUVID Question 2.3)
研究概览
简要总结
The purpose of this study is to compare the visual disturbance profile of an intraocular lens (IOL) using nondiffractive optics, the VIVITY IOL, to two diffractive IOLs in subjects requiring bilateral cataract surgery. IOLs are implantable medical devices intended for long-term use over the lifetime of the cataract patient.
详细描述
A total of 10 scheduled visits are planned. The visits include a screening visit, 2 operative visits, and 7 postoperative visits. Both eyes will be implanted. The second eye implant will occur within 7-21 days of the first eye implant. The primary endpoint data will be collected at the Month 3 visit. Individual subject participation is expected to last 6-7 months. This study will be conducted in Australia and New Zealand.
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
- Double (Participant, 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
- 否
入选标准
- •Planned cataract removal in both eyes.
- •Willing and able to complete all required postoperative visits.
- •Able to understand, read and write English and willing to sign an approved statement of informed consent.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Women of childbearing potential, pregnant, intend to become pregnant, breastfeeding.
- •Any eye condition, disease or pathology, other than cataract, that is expected to reduce postoperative best corrected distance visual acuity, as specified in the protocol.
- •Ocular trauma or ocular surface disease that would affect study measurements.
- •Patients who desire monovision correction.
- •Other protocol-specified exclusion criteria may apply.
结局指标
主要结局
Percentage of Subjects Not Bothered at All by Halos (QUVID Question 2.3)
时间窗: Month 3 postoperative (Day 120-180 from second eye surgery)
QUVID is a patient-reported outcomes questionnaire that collects responses from the subject about vision-related experiences. A halo is a circular spreading of light around a light source, such as car headlights at night. Question 2 of QUVID asked the subject, "In the past 7 days, have you experienced halos?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 2.3: "In the past 7 days, how much have your halos bothered you?" Subjects responded on a 5-point scale: 0=Not bothered at all; 1=Bothered a little bit; 2=Bothered somewhat; 3=Bothered quite a bit; 4=Bothered very much. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100.
次要结局
- Percentage of Subjects Not Bothered at All by Glare (QUVID Question 3.3)(Month 3 postoperative (Day 120-180 from second eye surgery))
- Percentage of Subjects Not Bothered at All by Starbursts (QUVID Question 1.3)(Month 3 postoperative (Day 120-180 from second eye surgery))