30 Participants Needed

Clareon Vivity IOLs with Mini-Monovision for Aphakia

SD
JC
Overseen ByJimmin Chang, PhD, RN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Debbie S. Kuo, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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?

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.678910

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

Potential acuity measured post-operatively 20/25 or better in both eyes
I have cataracts in both eyes and plan to get Clareon Vivity implants within 21 days.
IOL powers between +10D to +30.0D, T3-T6

Exclusion Criteria

I have had eye surgery.
I do not have eye or related diseases that significantly affect my vision.
I have eye conditions like irregular astigmatism, corneal dystrophies, or pupil abnormalities.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Bilateral implantation of Clareon Vivity and Clareon Vivity Toric IOLs targeted for mini-monovision

1 week
1 visit (in-person)

Follow-up

Participants are monitored for clinical outcomes and visual acuity post-surgery

3 months
2 visits (in-person)

Treatment Details

Interventions

  • Clareon Vivity and Clareon Vivity Toric
Trial OverviewThe 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).
Participant Groups
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

Who Is Running the Clinical Trial?

Debbie S. Kuo, MD

Lead Sponsor

Trials
1
Recruited
30+

Alcon Research

Industry Sponsor

Trials
739
Recruited
128,000+
Raquel C. Bono profile image

Raquel C. Bono

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott profile image

David Endicott

Alcon Research

Chief Executive Officer since 2018

MBA from University of Southern California

Findings from Research

In a study of 30 patients undergoing combined 23-gauge microincisional vitrectomy and cataract surgery, the AcrySof toric intraocular lens (IOL) significantly improved uncorrected visual acuity compared to the non-toric IOL at 1, 3, and 6 months post-surgery.
The toric IOL group also had a lower mean absolute residual refractive cylinder, indicating better astigmatism correction, while demonstrating good rotational stability, with 66.7% of lenses remaining within 5° of their intended axis after 6 months.
Combined 23-gauge microincisonal vitrectomy surgery and phacoemulsification with AcrySof toric intraocular lens implantation: a comparative study.Park, DH., Shin, JP., Kim, SY.[2022]
In a study involving 22 eyes from 16 patients undergoing cataract surgery, the foldable, injectable toric intraocular lens (IOL) significantly reduced refractive astigmatism, achieving an average of 73% of the planned correction.
Despite the overall success, 9% of the IOLs experienced significant rotation post-surgery, indicating a need for design improvements to enhance stability and predictability of outcomes.
Prospective evaluation of a plate haptic toric intraocular lens.Leyland, M., Zinicola, E., Bloom, P., et al.[2022]
In a study of 12 patients, combined 25-gauge microincision vitrectomy surgery (MIVS) and toric intraocular lens (IOL) implantation effectively improved visual acuity and significantly reduced corneal astigmatism after 6 months.
The procedure was safe, with no major complications reported, highlighting its practicality for treating patients with both vitreoretinal disease and cataracts.
Combined 25-gauge microincision vitrectomy and toric intraocular lens implantation with posterior capsulotomy.Kunikata, H., Aizawa, N., Meguro, Y., et al.[2015]

References

Combined 23-gauge microincisonal vitrectomy surgery and phacoemulsification with AcrySof toric intraocular lens implantation: a comparative study. [2022]
Prospective evaluation of a plate haptic toric intraocular lens. [2022]
Combined 25-gauge microincision vitrectomy and toric intraocular lens implantation with posterior capsulotomy. [2015]
Two-year results of AcrySof toric intraocular lens implantation in patients with combined microincision vitrectomy surgery and phacoemulsification. [2013]
Comparison of cataract patients with regular corneal astigmatism after implantation of extended range-of-vision and bifocal toric intraocular lenses. [2023]
Effectiveness and Safety of the Clareon Monofocal Intraocular Lens: Outcomes from a 12-Month Single-Arm Clinical Study in a Large Sample. [2022]
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]
Prospective functional and clinical comparison of bilateral ReZoom and ReSTOR intraocular lenses in patients 70 years or younger. [2008]
Three-year multinational clinical study on an aspheric hydrophobic acrylic intraocular lens. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Microincision Hydrophobic Acrylic Aspheric Toric Intraocular Lens for Astigmatism and Cataract Correction. [2015]
11.United Statespubmed.ncbi.nlm.nih.gov
Visual performance after bilateral toric extended depth-of-focus IOL exchange targeted for micromonovision. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
High-cylinder acrylic toric intraocular lenses: a case series of eyes with cataracts and large amounts of corneal astigmatism. [2012]