Clareon Vivity Toric IOL vs LAL+ for Cataracts

Overseen By Alisha Polson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Eye Associates

Must not be taking: UV sensitivity drugs

Disqualifiers: Corneal pathology, Macular disease, Glaucoma, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of lens implants for individuals with cataracts and regular astigmatism, a common vision issue. One group will receive the Clareon Vivity Toric IOL, while the other will receive the LAL+ lens. The trial aims to determine which lens better improves vision post-surgery. Candidates who have cataracts and astigmatism and require surgery on both eyes may be suitable, particularly if they have a stable vision profile and large pupils. As an unphased trial, it provides patients the chance to contribute to valuable research that could enhance future cataract treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medications that increase sensitivity to UV light or may harm the retina.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Clareon Vivity Toric IOL is safe and effective, with good long-term results. In a study of 810 patients, outcomes remained stable and safe, with few problems over time. Some patients might find it harder to see differences in shades, especially in dim light.

For the LAL+ lens, studies have demonstrated that it provides clear vision at different distances. The lens can be adjusted after surgery for precise vision correction. No major safety concerns emerged in the studies.

Both lenses have been well-studied and are generally well-tolerated, with no significant safety issues identified. However, every medical treatment carries some risks, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

The Clareon Vivity Toric IOL is unique because it offers extended depth of focus while correcting astigmatism, potentially reducing the need for glasses post-surgery. Unlike standard monofocal lenses, which typically provide clear vision at only one distance, this lens design allows for a broader range of vision. On the other hand, LAL+ (Light Adjustable Lens Plus) stands out due to its customization abilities after implantation, allowing precise adjustments to meet individual visual needs. Researchers are excited about these treatments because they represent advancements in personalized eye care, aiming for better visual outcomes for cataract patients.

What evidence suggests that this trial's treatments could be effective for cataracts?

This trial will compare the Clareon Vivity Toric IOL with the LAL+ lens for cataract treatment. Studies have shown that the Clareon Vivity Toric IOL improves vision for people with cataracts and astigmatism. The FDA has approved it, and it effectively corrects vision. Patients generally express high satisfaction, particularly with their ability to see clearly at middle distances.

For the LAL+ lens, another treatment option in this trial, research shows excellent vision results at various distances. Most patients achieve very good focus, with many seeing almost perfectly. The LAL+ lens also provides a wider range of clear vision, enhancing overall sight. ^{1 3 6 7 8}

Who Is on the Research Team?

Cathleen M McCabe, MD

Principal Investigator

The Eye Associates of Manatee

Are You a Good Fit for This Trial?

This trial is for adults with age-related cataracts and regular astigmatism who have not yet had surgery. Participants must be suitable for bilateral implantation of LAL+ IOLs in Phase 1, or willing to be randomly assigned to receive either LAL+ or Clareon Vivity Toric IOLs in Phase 2.

Inclusion Criteria

Subjects will have an expected monocular BCDVA outcomes of 20/25 or better in the opinion of the investigator

Subjects will be required to have a dilated pupil diameter of 7 mm or greater in both eyes

My eye condition can be corrected with a specific lens for astigmatism.

Exclusion Criteria

I have severe dry eye condition.

Irregular astigmatism

I have a history of glaucoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Ambispective, multi-site, single arm study in age-related cataract patients treated with LAL+ IOLs

Phase 2 Treatment

Prospective, randomized, unmasked, comparative study with subjects randomized to LAL+ or Clareon Vivity Toric IOLs

90 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Clareon Vivity Toric IOL
• LAL+

Trial Overview The study examines visual outcomes using two types of lens implants after cataract surgery: the RxSight LAL+ and Alcon's Clareon Vivity Toric IOL. Phase 1 observes patients with LAL+, while Phase 2 compares both lenses over a period of three months.

How Is the Trial Designed?

Group I: LAL+ Experimental Treatment 1 Intervention

Group II: Clareon Vivity Toric IOLs Active Control 1 Intervention

Who Is Running the Clinical Trial?

The Eye Associates

Lead Sponsor

Trials

3

Recruited

380+

Published Research Related to This Trial

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 117 patients undergoing bilateral implantation of toric intraocular lenses (IOLs) for cataracts and astigmatism, 99% achieved a binocular uncorrected distance visual acuity of 20/40 or better, demonstrating high efficacy in improving vision.

Patients reported high satisfaction with their vision post-surgery, with 94% rating their satisfaction as 7 or higher, and 69% of patients reported never needing distance spectacles after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visual function and patient experience after bilateral implantation of toric intraocular lenses. Ahmed, II., Rocha, G., Slomovic, AR., et al.[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 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]

Citations

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

Clinical Outcomes of Clareon Vivity Intraocular Lens With ... The Clareon Vivity and Vivity Toric lenses have been approved by the U.S. Food and Drug Administration (FDA) for visual correction of aphakia in adult patients ...

2. 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 ...

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

Evaluation of Clareon Vivity and PureSee intraocular lenses In the intermediate range, our Clareon Vivity IOL results of 0.05 logMAR at 67 cm were better than those reported by Shafer et al. in a ...

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

summary of safety and effectiveness data (ssed) Results achieved by the subjects followed for 6 months postoperatively (120 to 180 days after second eye implant) provide reasonable assurance that the AcrySof™ ...

5. myalcon.com myalcon.com/professional/cataract-surgery/iols/clareon-iol/

Clareon IOL for Cataract Surgery | Alcon Professional - MyAlcon In addition, the Clareon® Toric IOLs are indicated to correct pre-existing corneal astigmatism at the time of cataract surgery.

6. 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10964544/

3-years real-life outcomes of the Clareon® intraocular lens This real-life study reports high-performance and stable long-term refractive outcomes of the Clareon® IOL with good safety in terms of PCO and glistening.

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

Expanding the Clareon ® IOL Family STUDY OUTCOMES​​ The study included 810 real-world patients who had cataracts and were implanted bilaterally with the AcrySof IQ Vivity® IOL, ...