Evaluating Clareon Vivity Intraocular Lens with Mini-Monovision for Cataract Surgery
Clinical Outcomes of Clareon Vivity Intraocular Lens With Mini-Monovision Approach
This study is testing how well the Clareon Vivity lenses work for people having cataract surgery using a mini-monovision approach to see if it helps improve their vision without glasses.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Palo Alto Medical Foundation Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT05821101 on ClinicalTrials.gov |
What this trial studies
This study investigates the clinical outcomes of the Clareon Vivity and Clareon Vivity Toric intraocular lenses (IOLs) in patients undergoing cataract surgery using a mini-monovision approach. In this approach, the dominant eye is corrected for distance vision while the non-dominant eye is slightly nearsighted, enhancing the range of vision without glasses. The study aims to gather additional data on the effectiveness of these lenses, which have already been approved by the FDA for visual correction in aphakia. The procedures involved are not experimental, but the study seeks to provide further insights into their clinical outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults with bilateral age-related cataracts who are otherwise healthy and undergoing cataract surgery.
Not a fit: Patients with a history of ocular or refractive surgery or those with significant ocular or systemic comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve visual outcomes for cataract surgery patients by providing a broader range of clear vision without the need for glasses.
How similar studies have performed: Other studies have shown positive outcomes with similar lens technologies and approaches, indicating a promising avenue for further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients with bilateral age-related visually significant cataracts in otherwise healthy eyes, undergoing bilateral sequential implantation within 21 days using Clareon Vivity and Clareon Vivity Torics * IOL powers between +10D to +30.0D, T3-T6 * Potential acuity measured post-operatively 20/25 or better in both eyes Exclusion Criteria: * History of ocular or refractive surgery * Ocular or systemic comorbidities that may alter or reduce visual acuity, contrast sensitivity, binocularity, or impair reading performance such as severe dry eye/ocular surface disease, glaucoma, macular degeneration, retinopathy, neuro-ophthalmic diseases, strabismus/amblyopia etc. * Patients with irregular astigmatism, corneal dystrophies, pupil abnormalities, zonular laxity * Intraoperative or postoperative complications
Where this trial is running
Palo Alto, California
- Palo Alto Medical Foundation — Palo Alto, California, United States (Recruiting)
Study contacts
- Study coordinator: Sharon De Paz, LVN
- Email: sharontanya.depaz@sutterhealth.org
- Phone: (650) 853-2424
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.