Evaluating vision performance with Clareon Vivity intraocular lenses
Evaluation of the Impact of Residual Astigmatism on the Visual Performance With Clareon Vivity
This study is testing how leftover astigmatism affects the vision of people who have had Clareon Vivity lenses put in after cataract surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Alcon Research Industry-sponsored |
| Locations | 3 sites (Bloomfield Hills, Michigan and 2 other locations) |
| Trial ID | NCT06784063 on ClinicalTrials.gov |
What this trial studies
This study aims to assess how residual astigmatism affects visual performance in patients who have received Clareon Vivity intraocular lenses (IOLs) after cataract surgery. Participants will have undergone cataract surgery and had the IOLs implanted in both eyes at least four months prior to enrollment. During a single visit, trial lenses will be used to simulate astigmatism and measure its impact on distance, intermediate, and near vision. The goal is to generate clinical data that can help improve patient outcomes post-surgery.
Who should consider this trial
Good fit: Ideal candidates are individuals who have had cataract surgery and received Clareon Vivity IOLs in both eyes at least four months prior to the study.
Not a fit: Patients with significant residual astigmatism or other clinically significant ocular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of visual performance in patients with residual astigmatism, leading to better treatment options.
How similar studies have performed: While this approach is focused on a specific IOL, similar studies have shown promise in understanding the effects of astigmatism on visual outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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; * BCDVA of 0 logMAR or better in each eye. Exclusion Criteria: * Residual astigmatism greater than or equal to 1.00 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.
Where this trial is running
Bloomfield Hills, Michigan and 2 other locations
- Grosinger, Spigelman & Grey Eye Surgeons, P.C — Bloomfield Hills, Michigan, United States (Recruiting)
- Key-Whitman Eye Center — Dallas, Texas, United States (Recruiting)
- Berkeley Eye Center — Sugar Land, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Alcon Call Center
- Email: alcon.medinfo@alcon.com
- Phone: 1-888-451-3937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.