Evaluation of the Impact of Residual Astigmatism on the Visual Performance With Clareon Vivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Mean difference in monocular Distance Corrected Near Visual Acuity (DCNVA) (40 cm) before and after inducing 1.0 D astigmatism - WTR
研究概览
简要总结
The purpose of this study is to generate clinical data to quantify the impact of residual astigmatism on the overall visual performance during distance, intermediate, and near viewing in patients implanted with Clareon Vivity IOLs.
详细描述
This single visit study is designed to help understand how vision is affected if the eye still has astigmatism after cataract surgery. Participants will be individuals who have already undergone cataract surgery and received a Clareon Vivity IOL in both eyes at least 4 months prior to study enrollment. During the study visit, trial lenses (glass lenses that are used during an eye exam) will be used to temporarily create the effect of astigmatism on the eye.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Able to understand and sign an Institution Review Board-approved informed consent form;
- •Willing and able to attend all scheduled study visits as required by the protocol;
- •Implanted with study IOLs in both eyes at least 4 months prior to study participation;
- •Best Corrected Distance Visual Acuity (BCDVA) of 0 logarithm minimum angle of resolution (logMAR) or better in each eye.
排除标准
- •Residual astigmatism greater than or equal to 1.00 diopter (D);
- •Clinically significant ocular conditions as specified in the protocol;
- •History of ocular surgeries other than limbal relaxing incisions
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
Clareon Vivity/Vivity Toric
Previous implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOLs, with previous implantation defined as at least 4 months prior to study participation.
干预措施: Clareon Vivity Extended Vision IOL (Device)
结局指标
主要结局
Mean difference in monocular Distance Corrected Near Visual Acuity (DCNVA) (40 cm) before and after inducing 1.0 D astigmatism - WTR
时间窗: Day 0, coinciding with IOL implantation at least 4 months prior to visit
DCNVA will be 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 will be 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 will be measured in logMAR, with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism will be reported. One eye (first implanted eye) will be assessed. This is a co-primary endpoint.
Mean difference in monocular Best Corrected Distance Visual Acuity (BCDVA) (4 meters) before and after inducing 1.0 diopter (D) astigmatism - ATR
时间窗: Day 0, coinciding with IOL implantation at least 4 months prior to visit
BCDVA will be assessed with best refractive correction in place at a distance of 4 m using ETDRS letter charts. Trial lenses will be 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 will be measured in logMAR, with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism will be reported. One eye (first implanted eye) will be assessed. This is a co-primary endpoint.
Mean difference in monocular Distance Corrected Intermediate Visual Acuity (DCIVA) (66 centimeters) before and after inducing 1.0 D astigmatism.- ATR
时间窗: Day 0, coinciding with IOL implantation at least 4 months prior to visit
DCIVA will be 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 will be 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 will be measured in logMAR, with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism will be reported. One eye (first implanted eye) will be assessed. This is a co-primary endpoint.
Mean difference in monocular Distance Corrected Near Visual Acuity (DCNVA) (40 cm) before and after inducing 1.0 D astigmatism - ATR
时间窗: Day 0, coinciding with IOL implantation at least 4 months prior to visit
DCNVA will be 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 will be 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 will be measured in logMAR, with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism will be reported. One eye (first implanted eye) will be assessed. This is a co-primary endpoint.
Mean difference in monocular Best Corrected Distance Visual Acuity (BCDVA) (4 meters) before and after inducing 1.0 diopter (D) astigmatism - WTR
时间窗: Day 0, coinciding with IOL implantation at least 4 months prior to visit
BCDVA will be 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 will be 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 will be measured 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 will be reported. One eye (first implanted eye) will be assessed. This is a co-primary endpoint.
Mean difference in monocular Distance Corrected Intermediate Visual Acuity (DCIVA) (66 centimeters) before and after inducing 1.0 D astigmatism - WTR
时间窗: Day 0, coinciding with IOL implantation at least 4 months prior to visit
DCIVA will be 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 will be 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 will be measured in logMAR, with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism will be reported. One eye (first implanted eye) will be assessed. This is a co-primary endpoint.
Mean Difference in Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) (66 Centimeters) Before and After Inducing 1.0 D Astigmatism - WTR
时间窗: 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.
Mean Difference in Monocular Distance Corrected Near Visual Acuity (DCNVA) (40 cm) Before and After Inducing 1.0 D Astigmatism - WTR
时间窗: 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.
Mean Difference in Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 Meters) Before and After Inducing 1.0 Diopter (D) Astigmatism - ATR
时间窗: 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.
Mean Difference in Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) (66 Centimeters) Before and After Inducing 1.0 D Astigmatism.- ATR
时间窗: 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.
Mean Difference in Monocular Distance Corrected Near Visual Acuity (DCNVA) (40 cm) Before and After Inducing 1.0 D Astigmatism - ATR
时间窗: 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.
Mean Difference in Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 Meters) Before and After Inducing 1.0 Diopter (D) Astigmatism - WTR
时间窗: 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.
次要结局
未报告次要终点