Clareon Vivity IOLs with Mini-Monovision for Aphakia
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Debbie S. Kuo, MD
No Placebo Group
Approved in 1 jurisdiction
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.
12345Is the Clareon Vivity IOL safe for humans?
Research on similar Clareon intraocular lenses (IOLs) shows they are generally safe for humans, with studies evaluating their safety over periods up to three years.
678910How 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.
1341112Eligibility 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.Participant Groups
The study is examining the effectiveness of Clareon Vivity and Clareon Vivity Toric intraocular lenses in achieving mini-monovision after cataract surgery. The dominant eye will be set for clear distance vision (emmetropia) while the non-dominant eye will be slightly nearsighted (-0.50).
1Treatment groups
Experimental Treatment
Group I: Mini-Monovision ArmExperimental Treatment1 Intervention
Bilateral implantation of Clareon Vivity and Clareon Vivity Toric IOLs targeted for mini-monovision.
Clareon Vivity and Clareon Vivity Toric is already approved in United States for the following indications:
🇺🇸 Approved in United States as Clareon Vivity for:
- 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
Research locations nearbySelect from list below to view details:
Palo Alto Medical FoundationPalo Alto, CA
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Who is running the clinical trial?
Debbie S. Kuo, MDLead Sponsor
Alcon ResearchIndustry Sponsor
References
Combined 23-gauge microincisonal vitrectomy surgery and phacoemulsification with AcrySof toric intraocular lens implantation: a comparative study. [2022]To compare AcrySof toric intraocular lens (IOL) and non-toric IOL in patients who had combined 23-gauge microincisional vitrectomy surgery (MIVS) and phacoemulsification for vitreoretinal diseases and cataract with pre-existing corneal astigmatism.
Prospective evaluation of a plate haptic toric intraocular lens. [2022]Standard intraocular lenses (IOL) only correct the spherical component of aphakic refractive error. This study describes clinical experience with a foldable, injectable, toric IOL.
Combined 25-gauge microincision vitrectomy and toric intraocular lens implantation with posterior capsulotomy. [2015]To evaluate the efficacy of combined 25-gauge microincision vitrectomy surgery (MIVS) and toric intraocular lens (IOL) implantation with posterior capsulotomy.
Two-year results of AcrySof toric intraocular lens implantation in patients with combined microincision vitrectomy surgery and phacoemulsification. [2013]To evaluate the effects and stability of AcrySof toric intraocular lens (IOL) implantation in patients who had combined microincision vitrectomy surgery (MIVS) and phacoemulsification for vitreoretinal diseases and cataract with corneal astigmatism.
Comparison of cataract patients with regular corneal astigmatism after implantation of extended range-of-vision and bifocal toric intraocular lenses. [2023]To compare the postoperative visual acuity and visual quality between extended range-of-vision and multifocal toric intraocular lens (IOLs) after implantation in cataract patients with regular corneal astigmatism.
Effectiveness and Safety of the Clareon Monofocal Intraocular Lens: Outcomes from a 12-Month Single-Arm Clinical Study in a Large Sample. [2022]This study assessed effectiveness and safety of the novel Clareon intraocular lens (IOL; model SY60CL; Alcon Vision LLC).
Randomized controlled clinical trial to evaluate different intraocular lenses for the surgical compensation of low to moderate-to-high regular corneal astigmatism during cataract surgery. [2022]To evaluate vector analysis, rotational stability, and visual outcomes after implantation of toric IOLs with low (
Prospective functional and clinical comparison of bilateral ReZoom and ReSTOR intraocular lenses in patients 70 years or younger. [2008]To compare clinical outcomes, functional vision, and spectacle freedom in patients 70 years or younger with bilateral ReSTOR (Alcon Laboratories) or ReZoom (Advanced Medical Optics) intraocular lenses (IOLs).
Three-year multinational clinical study on an aspheric hydrophobic acrylic intraocular lens. [2023]To present the results of a study investigating the 3-year effectiveness and safety of the Clareon single-piece intraocular lens (IOL).
Microincision Hydrophobic Acrylic Aspheric Toric Intraocular Lens for Astigmatism and Cataract Correction. [2015]To evaluate the efficacy and safety of a new acrylic one-piece toric intraocular lens (IOL).
Visual performance after bilateral toric extended depth-of-focus IOL exchange targeted for micromonovision. [2021]To evaluate overall patient satisfaction, spectacle independence, binocular visual acuity, rotational stability, prevalence of optical phenomena, and decentration and tilt after bilateral toric extended depth-of-focus intraocular lens (EDOF IOL) implantation targeted for micromonovision.
High-cylinder acrylic toric intraocular lenses: a case series of eyes with cataracts and large amounts of corneal astigmatism. [2012]To examine the stability and efficacy of high-cylinder power AcrySof toric intraocular lenses (IOLs), models SN60T6, SN60T7, SN60T8, and SN60T9 (Alcon Laboratories Inc).