Clareon Vivity IOLs with Mini-Monovision for Aphakia
Trial Summary
What is the purpose of this trial?
This trial is studying special lenses used in cataract surgery for patients needing surgery in both eyes. These lenses help provide clear vision at various distances. The study aims to see how well these lenses work with a mini-monovision approach, where one eye is set for distance vision and the other for near vision. Mini-monovision corrects one eye for distance vision and the other eye for near vision, providing high patient satisfaction and reduced spectacle dependence.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Clareon Vivity IOLs with Mini-Monovision for Aphakia?
Research on similar toric intraocular lenses (IOLs) shows they can effectively correct vision issues like astigmatism (a condition where the eye doesn't focus light evenly on the retina). Studies on AcrySof toric IOLs, which are similar to Clareon Vivity, indicate they improve visual acuity (sharpness of vision) and stability in patients with cataracts and corneal astigmatism.12345
Is the Clareon Vivity IOL safe for humans?
How is the Clareon Vivity IOL treatment different from other treatments for aphakia?
Clareon Vivity IOLs offer a unique approach by providing extended depth-of-focus, which can improve vision at multiple distances without the need for glasses, and are designed for stability and reduced optical disturbances. This treatment is particularly novel because it targets micromonovision, allowing one eye to focus slightly better at a different distance, enhancing overall visual performance.1341112
Eligibility Criteria
This trial is for adults with bilateral age-related cataracts who need both eyes operated on. They should have a potential post-op vision of 20/25 or better, require specific IOL powers, and be able to undergo two surgeries within 21 days using Clareon Vivity lenses. People with irregular astigmatism, eye diseases like glaucoma or macular degeneration, previous eye surgeries, or other conditions affecting vision are not eligible.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Bilateral implantation of Clareon Vivity and Clareon Vivity Toric IOLs targeted for mini-monovision
Follow-up
Participants are monitored for clinical outcomes and visual acuity post-surgery
Treatment Details
Interventions
- Clareon Vivity and Clareon Vivity Toric
Clareon Vivity and Clareon Vivity Toric is already approved in United States for the following indications:
- Visual correction of aphakia in adult patients following cataract surgery
- Reduction of residual refractive astigmatism in adult patients with pre-existing corneal astigmatism
Find a Clinic Near You
Who Is Running the Clinical Trial?
Debbie S. Kuo, MD
Lead Sponsor
Alcon Research
Industry Sponsor
Raquel C. Bono
Alcon Research
Chief Medical Officer since 2022
MD from Harvard Medical School
David Endicott
Alcon Research
Chief Executive Officer since 2018
MBA from University of Southern California