Clareon Vivity IOLs with Mini-Monovision for Aphakia

Overseen By Jimmin Chang, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Debbie S. Kuo, MD

Disqualifiers: Glaucoma, Macular degeneration, Retinopathy, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of certain eye lenses, called Clareon Vivity and Clareon Vivity Toric, for individuals undergoing cataract surgery in both eyes. It employs a mini-monovision approach, setting each eye to see slightly different distances to enhance overall vision. The trial seeks adults with cataracts in both eyes who have not had previous eye surgery and whose vision can be improved to at least 20/25 with the new lenses. This trial may suit those whose cataracts affect daily activities like reading or driving. As an unphased trial, it offers a unique opportunity to explore innovative lens options that could enhance vision and daily life.

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 and Clareon Vivity Toric IOLs are safe for cataract surgery with mini-monovision?

Research has shown that Clareon Vivity and Clareon Vivity Toric lenses are safe for use. The U.S. Food and Drug Administration (FDA) has approved these lenses to assist adults with aphakia, a condition where the natural eye lens is absent. This approval indicates that the lenses have met the FDA's stringent safety requirements.

Some patients have reported visual effects, such as starbursts and halos—bright circles around lights—after receiving the lenses. This occurred in about 1% to 2% of patients with a similar lens. Most individuals find these effects minimally bothersome.

Studies comparing Clareon Vivity lenses to others have demonstrated that Clareon Vivity performs as well as other available lenses. Overall, these lenses are generally well-tolerated, with few serious side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Clareon Vivity IOLs for aphakia because they offer a new approach to vision correction by using a unique extended depth of focus technology. Unlike standard monofocal lenses, which focus light on a single point, Clareon Vivity lenses spread light over a range, improving both distance and intermediate vision without the need for glasses. Additionally, the mini-monovision technique being explored could provide patients with even greater freedom from corrective eyewear by slightly adjusting one eye for near vision. This combination of advanced lens technology and innovative implantation strategy promises a more balanced and natural visual experience for patients.

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

Research has shown that Clareon Vivity and Clareon Vivity Toric lenses improve vision after cataract surgery. These lenses provide clearer vision at various distances, potentially reducing the need for glasses for close-up tasks. In this trial, participants will receive bilateral implantation of Clareon Vivity and Clareon Vivity Toric IOLs, targeted for mini-monovision. Another study found that using these lenses in mini-monovision helps balance distance and near vision. Most patients report high satisfaction with these lenses. Overall, evidence suggests that Clareon Vivity lenses effectively enhance vision for individuals with cataracts. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

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

IOL powers between +10D to +30.0D, T3-T6

I have cataracts in both eyes and plan to get Clareon Vivity implants within 21 days.

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Clareon Vivity and Clareon Vivity Toric

Trial Overview 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).

How Is the Trial Designed?

Group I: Mini-Monovision Arm Experimental Treatment 1 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

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

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

In a study of 30 patients aged 70 years or younger with bilateral cataracts, the ReSTOR intraocular lens (IOL) demonstrated superior near vision performance compared to the ReZoom IOL, particularly at 31 cm, leading to higher rates of spectacle freedom (72.7% vs. 50.0%).

Both IOL designs provided excellent uncorrected visual acuity, but patients with ReZoom experienced more severe halos, with 2 out of 15 patients opting not to receive a second IOL due to this issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective functional and clinical comparison of bilateral ReZoom and ReSTOR intraocular lenses in patients 70 years or younger. Chang, DF.[2008]

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined 25-gauge microincision vitrectomy and toric intraocular lens implantation with posterior capsulotomy. Kunikata, H., Aizawa, N., Meguro, Y., et al.[2015]

In a study involving 19 eyes from 14 patients with significant preoperative corneal astigmatism (average 4.00 D), high-cylinder power AcrySof toric intraocular lenses (IOLs) effectively reduced residual astigmatism to an average of 0.55 D three months after surgery.

The uncorrected distance visual acuity improved significantly from an average of 1.3 logMAR preoperatively to 0.11 logMAR postoperatively, demonstrating the IOLs' efficacy in enhancing vision after cataract surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-cylinder acrylic toric intraocular lenses: a case series of eyes with cataracts and large amounts of corneal astigmatism. Cervantes-Coste, G., Garcia-Ramirez, L., Mendoza-Schuster, E., et al.[2012]

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 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective evaluation of a plate haptic toric intraocular lens. Leyland, M., Zinicola, E., Bloom, P., et al.[2022]

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]

The study of 26 patients with regular corneal astigmatism showed that bilateral implantation of toric extended depth-of-focus intraocular lenses (EDOF IOL) significantly reduced astigmatism by an average of 1.31 diopters, leading to improved visual acuity across distance, intermediate, and near vision.

Postoperatively, 77% of patients reported being spectacle independent, and a high level of satisfaction was noted, with 95% of patients satisfied with their distance and intermediate vision, indicating the efficacy of this lens type in enhancing overall visual function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visual performance after bilateral toric extended depth-of-focus IOL exchange targeted for micromonovision. Georgiev, S., Palkovits, S., Hirnschall, N., et al.[2021]

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 involving 78 eyes from 39 patients, both low and moderate-to-high toric intraocular lenses (IOLs) significantly reduced refractive astigmatism post-surgery, demonstrating their effectiveness in correcting regular corneal astigmatism.

The low toric IOLs showed a tendency for overcorrection, while the moderate-to-high toric IOLs tended to undercorrect, which may be linked to misalignment during implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Emesz, M., Dexl, AK., Krall, EM., et al.[2022]

In a study of 20 patients undergoing combined microincision vitrectomy and cataract surgery, those receiving toric intraocular lenses (IOLs) had significantly better uncorrected visual acuity compared to those with non-toric IOLs at all postoperative time points up to 24 months.

The toric IOLs demonstrated excellent rotational stability, with 80% of lenses remaining within 5° of their intended axis after 24 months, making them a reliable option for correcting corneal astigmatism in patients with vitreoretinal diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-year results of AcrySof toric intraocular lens implantation in patients with combined microincision vitrectomy surgery and phacoemulsification. Lee, JY., Kang, KM., Shin, JP., et al.[2013]

The new acrylic one-piece toric intraocular lens (IOL) demonstrated effective outcomes, with 54.8% of eyes achieving the primary endpoint of 20/20 vision or better six months after surgery, and good visual acuity maintained one year postoperatively.

The IOL showed stability in alignment and low rates of complications, with only three eyes needing repositioning and two requiring Nd:YAG laser capsulotomy, indicating its safety and reliability for patients with corneal astigmatism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microincision Hydrophobic Acrylic Aspheric Toric Intraocular Lens for Astigmatism and Cataract Correction. Bissen-Miyajima, H., Negishi, K., Hieda, O., et al.[2015]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05821101

Clinical Outcomes of Clareon Vivity Intraocular Lens With ... Purpose is to study the clinical outcomes of Clareon Vivity and Clareon Vivity Toric intraocular lens (IOL) implants in patients who are planning to have ...

2. nature.com nature.com/articles/s41598-025-07970-y

Evaluation of Clareon Vivity and PureSee intraocular lenses In conclusion, this laboratory investigation demonstrated that the Clareon Vivity and the Tecnis PureSee can improve patients' visual function ...

3. withpower.com withpower.com/trial/phase-aphakia-3-2023-f7878

Clareon Vivity IOLs with Mini-Monovision for Aphakia Despite the overall success, 9% of the IOLs experienced significant rotation post-surgery, indicating a need for design improvements to enhance stability and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10053890/

Clinical Outcomes of a New Non-Diffractive Extended ... An isofocal EDOF lens with mini-monovision provided an extended range of functional vision up to 63 cm, resulting in usable uncorrected near vision.

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

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

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05852470?term=AREA%5BInterventionSearch%5D(vivity)%20AND%20AREA%5BStudyType%5D(INTERVENTIONAL)&rank=3

Study Details | Evaluation of Clareon Vivity/Vivity Toric This study seeks to generate clinical data from subjects previously implanted with the Clareon Vivity/Vivity Toric Intraocular Lenses (IOLs) or Clareon ...

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

Clareon® Toric Intraocular Lens (IOL) for Astigmatism | Alcon For the Clareon® Vivity® IOL, most patients implanted with the Vivity® IOL are likely to experience significant loss of contrast sensitivity as compared to a ...

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

summary of safety and effectiveness data (ssed) Bench studies demonstrated equivalent optical performance between the previously approved marketed AcrySof™ Toric IOL and the Clareon™ Toric IOL. Accordingly,.

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

Expanding the Clareon ® IOL Family In the parent AcrySof® IQ Vivity™ IOL clinical study, 1% to 2% of AcrySof® IQ Vivity™ IOL patients reported very bothersome starbursts, halos, ...