Clareon Vivity IOLs for Astigmatism

No longer recruiting at 3 trial locations

Overseen By Alcon Call Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alcon Research

Disqualifiers: Astigmatism, Ocular conditions, Surgeries, 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 aims to understand how leftover astigmatism, a common vision problem causing blurred vision, affects visual acuity at different distances after Clareon Vivity Extended Vision IOLs (intraocular lenses) implantation. These lenses are designed to improve vision for individuals with astigmatism. Suitable candidates for this trial have had these lenses implanted in both eyes at least four months ago and have no more than a mild level of leftover astigmatism. Participants will help researchers gather important data on the lenses' performance in everyday life. As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could enhance understanding of vision improvements in real-world settings.

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 prior data suggests that Clareon Vivity IOLs are safe for astigmatism?

Research shows that the Clareon Vivity Extended Vision IOL is generally safe for patients. These lenses improve vision by correcting astigmatism, a condition where the eye's surface isn't perfectly curved, during cataract surgery. Studies indicate they provide clear and stable vision over time.

The Clareon Vivity lenses block UV and blue light, protecting the eyes. This technology features in many lens designs and has FDA approval for eye surgeries. Reports suggest that side effects are rare, and most patients tolerate the lenses well. As a result, complications are uncommon, making these lenses a safe choice for most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Clareon Vivity Extended Vision IOLs for astigmatism because they offer a unique approach by combining extended depth of focus technology with toric correction. Unlike traditional monofocal intraocular lenses (IOLs) that primarily correct vision at a single distance, the Clareon Vivity IOLs provide patients with improved vision across multiple distances, reducing the dependence on glasses for everyday tasks. Additionally, they are specifically designed to correct astigmatism, which is a common vision issue that standard IOLs do not address effectively. This combination of features aims to enhance overall visual quality and patient satisfaction post-surgery.

What evidence suggests that Clareon Vivity IOLs are effective for astigmatism?

Research shows that Clareon Vivity Extended Vision IOLs, which participants in this trial will receive, effectively correct astigmatism, a condition where the eye doesn't focus light evenly, causing blurred vision. Studies have found that these lenses offer clear vision and lasting results. Evidence suggests that the AcrySof Toric intraocular lens, a similar product, effectively corrects astigmatism in the cornea, ranging from 0.67 to 4.11 diopters, with good results. Additionally, unpublished data indicate that 94% of eyes had less than 0.50 diopters of remaining astigmatism after treatment, showing a high success rate. Overall, these lenses improve vision at various distances, making them a promising choice for people with astigmatism. ^{1 3 4 6 7}

Who Is on the Research Team?

Clinical Trial Lead, Surgical CRD

Principal Investigator

Alcon Research, LLC

Are You a Good Fit for This Trial?

This trial is for patients with astigmatism who have had Clareon Vivity Extended Vision Intraocular Lenses (IOLs) implanted. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and vision requirements.

Inclusion Criteria

Willing and able to attend all scheduled study visits as required by the protocol

I have had the study's specific eye implants for at least 4 months.

Able to understand and sign an Institution Review Board-approved informed consent form

Exclusion Criteria

Other protocol-specified exclusion criteria may apply.

Residual astigmatism greater than or equal to 1.00 D

I do not have major eye problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Study Visit

Participants undergo a single study visit where trial lenses are used to induce astigmatism and visual acuity is assessed

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any immediate effects following the study visit

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Clareon Vivity Extended Vision IOL

Trial Overview The study aims to assess how well people see at various distances—near, intermediate, and far—with the Clareon Vivity IOLs after surgery for astigmatism. It will measure the effect of any remaining astigmatism on their vision quality.

How Is the Trial Designed?

Group I: Clareon Vivity/Vivity Toric Experimental Treatment 1 Intervention

Previous implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOLs, with previous implantation defined as at least 4 months prior to study participation.

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 AcrySof Toric intraocular lens (IOL) effectively corrects corneal astigmatism ranging from 0.67 to 4.11 diopters, providing good clinical outcomes and excellent stability over time, although some studies report minor overcorrections or undercorrections.

Improvements to the manufacturer's online calculator for this IOL could enhance accuracy by accounting for posterior corneal astigmatism and the variable distance between the IOL and cornea, which affects the conversion of IOL cylinder measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new slant on toric intraocular lens power calculation. Savini, G., Hoffer, KJ., Ducoli, P.[2013]

The three-piece hydrophobic monofocal intraocular lens (IOL) Model MA60NM demonstrated effective visual correction, with 95.5% of patients achieving a Best Spectacle-Corrected Visual Acuity (BSCVA) of 20/40 or better at 1 year, surpassing ISO grid rates.

The safety profile of the MA60NM lens was strong, with low rates of serious adverse events and clinically significant posterior capsular opacification (PCO) at 1.1% at 1 year and 2.2% at 3 years, indicating long-term safety and effectiveness of the Clareon® material.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effectiveness and safety of a three-piece acrylic hydrophobic intraocular lens modified with hydroxyethyl-methacrylate: an open-label, 3-year follow-up study. Maxwell, A., Suryakumar, R.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 of 191 eyes from 133 cataract patients, the implantation of the CT LUCIA 621P IOL resulted in excellent visual outcomes, with 74.9% of eyes achieving uncorrected visual acuity of 20/25 or better.

The procedure demonstrated high refractive predictability, with 84.8% of eyes within ±0.50D of emmetropia, and no significant adverse events related to the IOL were reported, indicating a safe and effective intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Clinical Experience with a New Hydrophobic Acrylic Single-Piece Monofocal Intraocular Lens. Schallhorn, SC., Teenan, D., Venter, JA., et al.[2023]

The Clareon single-piece intraocular lens (IOL) demonstrated excellent long-term effectiveness, with 99.5% of eyes achieving a corrected distance visual acuity (CDVA) of ≤0.3 logMAR at 1 year and 93.4% achieving 0.1 logMAR or better at 3 years, indicating stable visual outcomes over time.

The safety profile of the Clareon IOL was strong, with low rates of adverse events, 100% of lenses showing no significant glistenings, and 92.9% of eyes having no or clinically nonsignificant posterior capsule opacification (PCO) after 3 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-year multinational clinical study on an aspheric hydrophobic acrylic intraocular lens. Nuijts, RMMA., Bhatt, U., Nanavaty, MA., et al.[2023]

The study compared two types of intraocular lenses (IOLs) in cataract patients: the bifocal toric (ZMT) and the extended range-of-vision (ZXR), finding that the ZMT lens provided better uncorrected distance and near visual acuity, while the ZXR lens excelled in uncorrected intermediate visual acuity and reduced optical disturbances like halos and glare.

Both lenses effectively improved visual outcomes, with the ZMT lens significantly reducing postoperative astigmatism and high-order aberrations, suggesting that each lens type has unique benefits for different visual needs in patients with regular corneal astigmatism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of cataract patients with regular corneal astigmatism after implantation of extended range-of-vision and bifocal toric intraocular lenses. Li, Z., Guo, R., Hu, X., et al.[2023]

In a study involving 350 adults undergoing cataract surgery, 99.7% of participants achieved excellent visual acuity (CDVA ≤0.3 logMAR) 12 months after receiving the Clareon intraocular lens (IOL), indicating its high effectiveness.

The safety profile of the Clareon IOL was favorable, with serious adverse events occurring in less than 1% of subjects, and the most common nonserious issue being posterior capsule opacification in 5.4% of cases, which is within expected limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of the Clareon Monofocal Intraocular Lens: Outcomes from a 12-Month Single-Arm Clinical Study in a Large Sample. Lehmann, R., Maxwell, A., Lubeck, DM., et al.[2022]

In a study of 30 patients with preoperative corneal astigmatism, the implantation of Symfony toric extended range of vision intraocular lenses resulted in significant improvements in visual acuity, with 96% achieving excellent uncorrected intermediate vision and 82% achieving good near vision after 3 months.

The procedure was found to be safe, with high patient satisfaction scores (median of 9.0 for distance and intermediate vision) and a majority of patients reporting complete independence from glasses, while only 11% experienced bothersome photic phenomena.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rotational stability and visual performance 3 months after bilateral implantation of a new toric extended range of vision intraocular lens. Gundersen, KG.[2022]

Citations

1. myalcon.com myalcon.com/professional/cataract-surgery/iols/clareon-toric/

Clareon® Toric Intraocular Lens (IOL) for Astigmatism | Alcon Clareon® Toric IOLs provide exceptional clarity1,2*, allowing you to confidently deliver the long-lasting refractive outcomes that your patients expect.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06784063

NCT06784063 | Visual Performance With Clareon® Vivity® ... The purpose of this study is to generate clinical data to quantify the impact of residual astigmatism on the overall visual performance during distance, ...

3. withpower.com withpower.com/trial/clareon-vivity-iols-for-astigmatism-5e1f3

Clareon Vivity IOLs for Astigmatism · Info for Participants The AcrySof Toric intraocular lens (IOL) effectively corrects corneal astigmatism ranging from 0.67 to 4.11 diopters, providing good clinical outcomes and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12345935/

Clinical and Patient-Reported Outcomes After Mix-and-Match ... Mix-and-match implantation of the Clareon PanOptix and Vivity IOLs yields good patient satisfaction potentially by combining the advantages of ...

5. crstoday.com crstoday.com/articles/expanding-the-clareon-iol-family/expanding-the-clareon-iol-family

Expanding the Clareon ® IOL Family Table 1 shows that 94% of these eyes had an overall residual refractive astigmatism of <0.50 D (unpublished data).

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/P190018B.pdf

summary of safety and effectiveness data (ssed) The ClareonTM and ClareonTM Toric Aspheric Hydrophobic Acrylic IOLs are ultraviolet and blue light filtering foldable single-piece posterior chamber intraocular ...

7. clevelandeyeclinic.com clevelandeyeclinic.com/cataracts-ohio/vivity-iol/

Vivity™ Lens: Cataract & Astigmatism Correction Your astigmatism can be corrected at the time of cataract surgery with a special Vivity toric lens, which is specifically designed to correct astigmatism.