Clareon® Vivity® 人工晶状体 (IOL) 的视觉性能
2026年7月10日 更新者：Alcon Research
使用 Clareon Vivity 评估残余散光对视觉性能的影响
本研究的目的是生成临床数据，以量化残余散光对植入 Clareon Vivity IOL 的患者在远距离、中距离和近距离观看时整体视觉表现的影响。
研究概览
详细说明
这项单次访问研究旨在帮助了解白内障手术后眼睛仍然散光时视力如何受到影响。
参与者将是在研究入组前至少 4 个月已经接受过白内障手术并双眼接受了 Clareon Vivity IOL 的个人。
在研究访问期间，将使用试用镜片（眼科检查期间使用的玻璃镜片）暂时对眼睛产生散光效果。
研究类型
介入性
注册 (实际的)
40
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Michigan
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Bloomfield Hills、Michigan、美国、48302
- Grosinger, Spigelman & Grey Eye Surgeons, P.C
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Texas
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Dallas、Texas、美国、75243
- Key-Whitman Eye Center
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Sugar Land、Texas、美国、77478
- Berkeley Eye Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
纳入标准：
- 能够理解并签署机构审查委员会批准的知情同意书；
- 愿意并且能够按照方案的要求参加所有预定的研究访问；
- 在参与研究前至少 4 个月在双眼中植入研究 IOL；
- 每只眼睛的 BCDVA 为 0 logMAR 或更好。
排除标准：
- 残余散光大于或等于1.00D；
- 方案中指定的具有临床意义的眼部疾病；
- 除角膜缘松弛切口外的眼科手术史
- 其他协议指定的排除标准可能适用。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Clareon Vivity/Vivity Toric
双眼之前曾植入过 Clareon Vivity/Vivity Toric 远景人工晶状体，之前植入定义为参与研究前至少 4 个月。
|
白内障手术期间植入眼囊袋中的扩展视力人工晶状体。
IOL 旨在让白内障患者终生长期使用。
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean Difference in Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 Meters) Before and After Inducing 1.0 Diopter (D) Astigmatism - WTR
大体时间：Day 0 before induced astigmatism; Day 0 after induced astigmatism
|
BCDVA was assessed with best refractive correction in place at a distance of 4 meters (m) using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts.
Trial lenses were used to induce 1.0 diopter (D) of astigmatism with-the-rule (WTR), defined as -0.50/+1.00
D at approximately 180 degrees on the optical axis.
VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity.
The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA.
No hypothesis testing was prespecified for this co-primary endpoint.
|
Day 0 before induced astigmatism; Day 0 after induced astigmatism
|
|
Mean Difference in Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) (66 Centimeters) Before and After Inducing 1.0 D Astigmatism - WTR
大体时间：Day 0 before induced astigmatism; Day 0 after induced astigmatism
|
DCIVA was assessed with distance correction in place (plus or minus power) at a distance of 66 centimeters (cm) from the spectacle plane using ETDRS letter charts.
Trial lenses were used to induce 1.0 D of astigmatism with-the-rule (WTR), defined as -0.50/+1.00
D at approximately 180 degrees on the optical axis.
VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity.
The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA.
No hypothesis testing was prespecified for this co-primary endpoint.
|
Day 0 before induced astigmatism; Day 0 after induced astigmatism
|
|
Mean Difference in Monocular Distance Corrected Near Visual Acuity (DCNVA) (40 cm) Before and After Inducing 1.0 D Astigmatism - WTR
大体时间：Day 0 before induced astigmatism; Day 0 after induced astigmatism
|
DCNVA was assessed with distance correction in place (plus or minus power) at a distance of 40 cm from the spectacle plane using ETDRS letter charts.
Trial lenses were used to induce 1.0 D of astigmatism WTR, defined as -0.50/+1.00
D at approximately 180 degrees on the optical axis.VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity.
The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA.
No hypothesis testing was prespecified for this co-primary endpoint.
|
Day 0 before induced astigmatism; Day 0 after induced astigmatism
|
|
Mean Difference in Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 Meters) Before and After Inducing 1.0 Diopter (D) Astigmatism - ATR
大体时间：Day 0 before induced astigmatism; Day 0 after induced astigmatism
|
BCDVA was assessed with best refractive correction in place at a distance of 4 m using ETDRS letter charts.
Trial lenses were used to induce 1.0 D of astigmatism against the rule (ATR), defined as -0.50/+1.00
D at approximately 90 degrees on the optical axis.
VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity.
The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA.
No hypothesis testing was prespecified for this co-primary endpoint.
|
Day 0 before induced astigmatism; Day 0 after induced astigmatism
|
|
Mean Difference in Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) (66 Centimeters) Before and After Inducing 1.0 D Astigmatism.- ATR
大体时间：Day 0 before induced astigmatism; Day 0 after induced astigmatism
|
DCIVA was assessed with distance correction in place (plus or minus power) at a distance of 66 cm from the spectacle plane using ETDRS letter charts.
Trial lenses were used to induce 1.0 D of astigmatism ATR, defined as -0.50/+1.00
D at approximately 90 degrees on the optical axis.
VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity.
The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA.
No hypothesis testing was prespecified for this co-primary endpoint.
|
Day 0 before induced astigmatism; Day 0 after induced astigmatism
|
|
Mean Difference in Monocular Distance Corrected Near Visual Acuity (DCNVA) (40 cm) Before and After Inducing 1.0 D Astigmatism - ATR
大体时间：Day 0 before induced astigmatism; Day 0 after induced astigmatism
|
DCNVA was assessed with distance correction in place (plus or minus power) at a distance of 40 cm from the spectacle plane using ETDRS letter charts.
Trial lenses were used to induce 1.0 D of astigmatism ATR, defined as -0.50/+1.00
D at approximately 90 degrees on the optical axis.
VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity.
The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA.
No hypothesis testing was prespecified for this co-primary endpoint.
|
Day 0 before induced astigmatism; Day 0 after induced astigmatism
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Clinical Trial Lead, Surgical CRD、Alcon Research, LLC
出版物和有用的链接
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有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年4月10日
初级完成 (实际的)
2025年6月13日
研究完成 (实际的)
2025年6月13日
研究注册日期
首次提交
2025年1月15日
首先提交符合 QC 标准的
2025年1月15日
首次发布 (实际的)
2025年1月20日
研究记录更新
最后更新发布 (实际的)
2026年7月13日
上次提交的符合 QC 标准的更新
2026年7月10日
最后验证
2026年7月1日
更多信息
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