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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the long-term effectiveness of AcrySof IQ Vivity intraocular lenses (IOLs) in individuals who have undergone cataract surgery. The researchers aim to determine the safety and effectiveness of these lenses in everyday life. Individuals who received AcrySof IQ Vivity lenses in both eyes 3-5 years ago may qualify. The study will assess how these lenses improve vision post-cataract surgery. As an unphased trial, it offers participants the chance to contribute to valuable research on the long-term benefits of these lenses.

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 prior data suggests that the AcrySof IQ Vivity IOL models are safe?

Research has shown that the AcrySof IQ Vivity Extended Vision lens is a well-tolerated option for people undergoing cataract surgery. Studies have found that this lens provides clear vision for both far and middle distances. Importantly, it is as safe as the standard lenses commonly used in these surgeries.

The lens employs special technology to reduce visual disturbances that some people experience with other lenses. Overall, evidence suggests that the AcrySof IQ Vivity lens is safe for patients, with few reports of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional intraocular lenses (IOLs) used in cataract surgery that primarily focus on improving vision at a single distance, the AcrySof IQ Vivity Extended Vision IOL offers an extended depth of focus. This means it can enhance vision across a wider range of distances, potentially reducing the need for glasses after surgery. Researchers are excited about this treatment because it employs a unique wavefront-shaping technology, which helps provide clearer vision without compromising contrast sensitivity or causing disturbing visual halos, a common issue with other multifocal IOLs. This innovation could significantly improve the quality of life for those with presbyopia, offering a more seamless visual experience.

What is the effectiveness track record for AcrySof IQ Vivity IOL for presbyopia?

Research shows that the AcrySof IQ Vivity Extended Vision intraocular lens (IOL) effectively improves vision for individuals with presbyopia, a condition where the ability to see up close diminishes with age. Studies have found that this lens provides clear vision for both far and middle distances, simplifying everyday tasks. Over 900 patients reported high satisfaction and reduced dependence on glasses after cataract surgery with this lens. The AcrySof IQ Vivity lens employs special technology to enhance vision without causing additional issues like halos or glare, which can occur with other lenses. Overall, this lens is well-received and effective for those needing improved vision due to presbyopia. ^{1 2 3 6 7}

Who Is on the Research Team?

Clinical Trial Management Operations, Surgical

Principal Investigator

Alcon Research, LLC

Are You a Good Fit for This Trial?

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

Able to understand and sign an approved informed consent form

Documented medical history and required pre-operative baseline information available for retrospective data collection

Other protocol-specified inclusion criteria may apply

Exclusion Criteria

Pregnant or nursing at the time of enrollment

Childbirth after IOL implantation

Other protocol-specified exclusion criteria may apply

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

Citations

1. nature.com nature.com/articles/s41598-024-69960-w

Functional outcomes and quality of life after AcrySof IQ ... AcrySof IQ Vivity is a well-tolerated and effective IOL with optimal refractive target for both distant and intermediate vision, needing slight spherical ...

2. myalcon.com myalcon.com/international/professional/cataract-surgery/iols/vivity/

AcrySof® IQ Vivity® Extended Depth of Focus IOL | Alcon Global The first and only presbyopia-correcting IOL with wavefront-shaping technology and a clinically proven monofocal visual disturbance profile.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11149524/

Visual performance and patient satisfaction with AcrySof® IQ ... This study concludes that Vivity IOL provides a good extended range of vision, with good distance and intermediate vision, which are useful for the daily ...

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P930014S126B.pdf

SUMMARY of SAFETY and EFFECTIVENESS DATA (SSED) The AcrySof™ IQ Vivity™ Extended Vision IOL Model DFT015 is indicated for primary implantation for the visual correction of aphakia in adult ...

5. alcon.com alcon.com/media-release/cataract-surgery-alcons-acrysof-iq-vivity-iols-demonstrates-sustained-high-patient/

Cataract Surgery with Alcon's AcrySof IQ Vivity IOLs ... Data from more than 900 cataract patients demonstrated sustained clinical performance, high patient satisfaction and reduced dependence upon spectacles ( ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06541795?term=AREA%5BInterventionSearch%5D(vivity)%20AND%20AREA%5BStudyType%5D(INTERVENTIONAL)&rank=8

Evaluation of AcrySof IQ Vivity Extended Vision Intraocular ... 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) ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10983649/

Non-diffractive, toric, extended depth-of-focus intraocular ... Our results show that implanting AcrySof IQ Vivity T2 IOLs in cataract patients with low corneal astigmatism offers excellent visual performance ...