AcrySof IQ Vivity IOL for Presbyopia

Overseen By Alcon Call Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alcon Research

Disqualifiers: Corneal surgery, Pregnancy, Childbirth, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

210 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this post-market study is to describe the long-term safety and performance of AcrySof IQ Vivity and AcrySof IQ Vivity Toric intraocular lens (IOL) models in a real-world setting through routine clinical practice.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the AcrySof IQ Vivity IOL treatment for presbyopia?

The AcrySof IQ Vivity IOL has been shown to provide an extended range of focus, offering a smoother transition from far to intermediate vision compared to other lenses. This suggests it may help reduce the need for glasses and improve overall vision quality for people with presbyopia. ^{1 2 3 4 5}

What makes the AcrySof IQ Vivity IOL treatment unique for presbyopia?

The AcrySof IQ Vivity IOL is unique because it uses non-diffractive X-WAVE technology to provide an extended range of vision, offering a smoother transition from far to intermediate distances without the visual disturbances often associated with diffractive lenses. ^{1 2 3 4 6}

Research Team

Clinical Trial Management Operations, Surgical

Principal Investigator

Alcon Research, LLC

Eligibility Criteria

This trial is for individuals who have had their natural lens removed (aphakia), struggle with near vision due to aging (presbyopia), or have blurred vision caused by an irregularly shaped cornea (astigmatism).

Inclusion Criteria

Other protocol-specified inclusion criteria may apply

I am 22 years old or older.

Able to understand and sign an approved informed consent form

Exclusion Criteria

I had eye surgery to correct my vision after getting a Vivity lens implant.

Pregnant or nursing at the time of enrollment

Childbirth after IOL implantation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Retrospective Chart Review

Retrospective chart review to obtain preoperative, operative, and post-operative data

Not specified

Prospective Visit

One prospective visit to collect key long-term safety and performance endpoints

1 visit

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3-5 years

Treatment Details

Interventions

• AcrySof IQ Vivity Extended Vision IOL

Trial Overview The study is evaluating the long-term safety and effectiveness of AcrySof IQ Vivity Extended Vision IOLs, which are artificial lenses implanted in the eye to improve vision after cataract surgery.

Participant Groups

Group I: AcrySof IQ Vivity Extended Vision IOL and AcrySof IQ Vivity Toric Extended Vision IOL Experimental Treatment 1 Intervention

AcrySof IQ Vivity Extended Vision IOL implanted in both eyes during cataract surgery

Who Is Running the Clinical Trial?

Alcon Research

Lead Sponsor

Trials

739

Recruited

128,000+

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

Findings from Research

Patients with the AcrySof IQ Vivity IOL reported significantly less glare and halo effects in low light conditions compared to those with other multifocal IOLs, indicating a better visual comfort profile.

While the Vivity IOL provided comparable rates of complete spectacle independence to some other IOL types, it was significantly lower than the PanOptix IOL, suggesting that while Vivity offers advantages, it may not achieve the same level of spectacle independence as the best-performing multifocal options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Vivity Extended Range of Vision IOL vs the PanOptix Trifocal, ReStor 2.5 Active Focus and ReStor 3.0 Multifocal Lenses: A Comparison of Patient Satisfaction, Visual Disturbances, and Spectacle Independence. Hovanesian, JA., Jones, M., Allen, Q.[2022]

The study evaluated 45 eyes with low-grade epiretinal membrane (ERM) and found that their visual outcomes after implantation of the AcrySof® Vivity® intraocular lens (IOL) were comparable to 50 control eyes without ERM, indicating the lens's efficacy in this condition.

While uncorrected intermediate visual acuity and mesopic contrast sensitivity were significantly worse in eyes with ERM, overall visual acuity was similar between both groups, suggesting that the Vivity IOL can still be beneficial for patients with low-grade, reversible ERM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes after implantation of extended depth-of-focus AcrySof® Vivity® intraocular lens in eyes with low-grade epiretinal membrane. Jeon, S., Choi, A., Kwon, H.[2022]

The AcrySof IQ PanOptix IOL offers a more natural intermediate focal point of 60 cm, enhancing comfort for tasks like using computers, compared to traditional trifocal IOLs with an 80 cm focal point.

Clinical evidence from 12 studies indicates that the PanOptix IOL provides good visual outcomes and high spectacle independence, similar to other multifocal and extended depth of focus IOLs, but individual patient needs must be considered for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AcrySof IQ PanOptix Intraocular Lens Versus Extended Depth of Focus Intraocular Lens and Trifocal Intraocular Lens: A Clinical Overview. Sudhir, RR., Dey, A., Bhattacharrya, S., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Innovative trifocal (quadrifocal) presbyopia-correcting IOLs: 1-year outcomes from an international multicenter study. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

The Vivity Extended Range of Vision IOL vs the PanOptix Trifocal, ReStor 2.5 Active Focus and ReStor 3.0 Multifocal Lenses: A Comparison of Patient Satisfaction, Visual Disturbances, and Spectacle Independence. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Visualization of Ray Propagation through Extended Depth-of-Focus Intraocular Lenses. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

A Cost-Effectiveness Analysis of AcrySof IQ Vivity Intraocular Lens (IOL) from Private Health Fund Perspective in Australia. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Clinical outcomes after implantation of extended depth-of-focus AcrySof® Vivity® intraocular lens in eyes with low-grade epiretinal membrane. [2022]

6. China pubmed.ncbi.nlm.nih.gov

AcrySof IQ PanOptix Intraocular Lens Versus Extended Depth of Focus Intraocular Lens and Trifocal Intraocular Lens: A Clinical Overview. [2019]