Visual Performance With Clareon® Vivity® Intraocular Lenses (IOLs)
United States40 participantsStarted 2025-04-10
Plain-language summary
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.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Difference in Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 Meters) Before and After Inducing 1.0 Diopter (D) Astigmatism - WTR
Timeframe: Day 0 before induced astigmatism; Day 0 after induced astigmatism
2
Mean Difference in Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) (66 Centimeters) Before and After Inducing 1.0 D Astigmatism - WTR
Timeframe: Day 0 before induced astigmatism; Day 0 after induced astigmatism
3
Mean Difference in Monocular Distance Corrected Near Visual Acuity (DCNVA) (40 cm) Before and After Inducing 1.0 D Astigmatism - WTR
Timeframe: Day 0 before induced astigmatism; Day 0 after induced astigmatism
4
Mean Difference in Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 Meters) Before and After Inducing 1.0 Diopter (D) Astigmatism - ATR
Timeframe: Day 0 before induced astigmatism; Day 0 after induced astigmatism
5
Mean Difference in Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) (66 Centimeters) Before and After Inducing 1.0 D Astigmatism.- ATR
Timeframe: Day 0 before induced astigmatism; Day 0 after induced astigmatism