Long-term safety and performance evaluation of Clareon IOLs after cataract surgery
Long-term Evaluation of Safety and Performance of Clareon Presbyopia-Correcting Intraocular Lenses (IOLs)
This study is testing how safe and effective Clareon Vivity and Clareon PanOptix lenses are for people who had cataract surgery a few months ago, by following them for three years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 480 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Alcon Research Industry-sponsored |
| Locations | 7 sites (Torrance, California and 6 other locations) |
| Trial ID | NCT05796453 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the long-term safety and performance of Clareon Vivity and Clareon PanOptix intraocular lenses (IOLs) in patients who have undergone cataract surgery. Participants will be recruited from those who had bilateral implantation of these lenses 3-6 months prior to enrollment. The study will collect both retrospective data from pre-operative and surgical visits, as well as prospective data through a follow-up period of three years to monitor any safety outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals who have had bilateral implantation of Clareon Vivity or Clareon PanOptix IOLs within the last 3-6 months.
Not a fit: Patients who have undergone corneal refractive surgery after lens implantation or are currently participating in another investigational study may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of Clareon IOLs, potentially improving patient outcomes in cataract surgery.
How similar studies have performed: Other studies evaluating the safety and performance of IOLs have shown promising results, indicating that this approach is supported by previous research.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Subject or legally authorized representative must be able to understand and sign an approved Informed Consent Form. * Subject must have had bilateral implantation of Clareon Vivity, Clareon Vivity Toric, Clareon PanOptix, or Clareon PanOptix Toric IOLs between 3-6 months prior to enrollment. * Subject must have a documented medical history and required pre-operative baseline information available for retrospective data collection. * Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: * Subject is currently participating in another investigational drug or device study. * Subject has had corneal refractive surgery after Clareon Vivity, Clareon Vivity Toric, Clareon PanOptix, or Clareon PanOptix Toric IOL implantation. * Subject is pregnant at the time of enrollment. * Other protocol-defined exclusion criteria may apply.
Where this trial is running
Torrance, California and 6 other locations
- Wolstan & Goldberg Eye Associates — Torrance, California, United States (Recruiting)
- Levenson Eye Associates — Jacksonville, Florida, United States (Recruiting)
- Eye Surgeons of CNY — Liverpool, New York, United States (Recruiting)
- Tulsa Ophthalmology — Tulsa, Oklahoma, United States (Recruiting)
- Chu Eye Institute — Fort Worth, Texas, United States (Recruiting)
- The Eye Institute of Utah — Salt Lake City, Utah, United States (Recruiting)
- Centro Oftalmologico Metropolitano — San Juan, Puerto Rico (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.