Intraocular Lenses for Cataracts

Enrolling by invitation at 4 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Brian Shafer
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare different lens implants for cataract patients, focusing on vision and satisfaction. One group will receive different lenses in each eye, while another will receive the same lens in both eyes. The researchers aim to determine if different lenses provide similar or better vision, particularly in reducing visual disturbances like halos and glare. Individuals with age-related cataracts seeking treatment for both eyes might be suitable for this study. The lenses under study include Clareon PanOptix Pro and Clareon Vivity. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance cataract treatment options.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these intraocular lenses are safe for cataract patients?

Research has shown that the Clareon PanOptix Pro and Clareon Vivity lenses are generally well-tolerated by patients. For the Clareon PanOptix Pro, safety data from earlier studies showed good results with low risks of complications or serious side effects. Most patients achieved the desired vision correction with few problems.

Similarly, studies on the Clareon Vivity lens have shown it is safe for cataract patients. Some individuals might notice slight difficulty distinguishing different shades of the same color, but this lens still provides good overall vision. Both lenses are designed to improve vision after cataract surgery, focusing on reducing unwanted visual effects like halos or glare.

In summary, previous studies have demonstrated that both the Clareon PanOptix Pro and Clareon Vivity lenses are safe and effective, offering promising options for cataract patients seeking to improve their vision.12345

Why are researchers excited about this trial?

Researchers are excited about Clareon PanOptix Pro and Clareon Vivity intraocular lenses for cataracts because they offer unique benefits not typically seen with standard monofocal lenses. Clareon PanOptix Pro is a trifocal lens designed to improve vision at near, intermediate, and far distances, potentially reducing the need for glasses after surgery. Meanwhile, Clareon Vivity uses non-diffractive technology to extend the range of vision, providing clearer vision in various lighting conditions without the halo and glare often associated with other multifocal lenses. These advancements could significantly enhance the quality of life for patients with cataracts by delivering a broader range of vision and greater visual comfort.

What evidence suggests that these intraocular lenses are effective for cataracts?

This trial will compare the effectiveness of different intraocular lenses for cataract surgery. Research has shown that the Clareon PanOptix Pro lens, which participants in one arm of this trial may receive bilaterally, is highly effective, with 87% of people achieving 20/20 vision after surgery. It efficiently uses light, enhancing clarity, and studies report less light scatter, reducing glare issues.

In contrast, the Clareon Vivity lens, which participants in another arm may receive in one eye, offers good vision at various distances, particularly improving vision for tasks like reading or using a computer. However, it may cause some loss in contrast sensitivity, making things appear less sharp, especially in dim lighting. Both lenses aim to improve vision after cataract surgery, each with its own strengths.13567

Who Is on the Research Team?

BS

Brian Shafer, MD

Principal Investigator

Shafer Vision Institute

Are You a Good Fit for This Trial?

Adults with bilateral age-related cataracts who are planning to have both eyes operated on for cataract removal. They should expect good vision post-surgery (20/25 or better) and have minimal astigmatism. People with corneal issues, macular disease, glaucoma, previous eye surgeries, amblyopia, severe dry eye, high levels of irregular vision surface (high HOA), a preference for monovision correction, active infections or inflammation in the eye area, or those who are pregnant cannot participate.

Inclusion Criteria

I have cataracts in both eyes due to aging.
Expected best monocular corrected distance visual acuity (BCDVA) of 0.1 logMAR (Snellen 20/25) or better in both eyes postoperatively
I am 18 or older and can agree to participate in the study.
See 3 more

Exclusion Criteria

I have glaucoma.
My eye condition involves weak or broken fibers.
I have a history of lazy eye or poor 3D vision.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

First Eye Surgery

Participants undergo cataract surgery on the first eye with either PanOptix Pro or Clareon Vivity IOL implantation

1 day
1 visit (in-person)

Second Eye Surgery

Participants undergo cataract surgery on the second eye within 4 weeks of the first surgery

1 day
1 visit (in-person)

Follow-up

Participants are monitored for visual outcomes and adverse events post-surgery

3 months
1 visit (in-person) at 3 months post-operative

What Are the Treatments Tested in This Trial?

Interventions

  • Clareon PanOptix Pro
  • Clareon Vivity
Trial Overview The study is testing visual outcomes and satisfaction in patients receiving two different types of lens implants after cataract surgery: one group gets PanOptix Pro lenses in both eyes; another group gets a PanOptix Pro lens in one eye and a Clareon Vivity lens in the other. The trial involves 346 participants across multiple centers and includes comprehensive visual assessments.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Contralateral PanOptix Pro and Clareon VivityExperimental Treatment1 Intervention
Group II: Bilateral PanOptix ProActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brian Shafer

Lead Sponsor

Citations

Clareon®️ PanOptix®️ Pro: Surgeons Share Early Insights50% less light scatter, the lowest reported light scatter of any trifocal IOL. · Unprecedented 94% light utilization in trifocal IOLs, compared ...
Post Market Clinical Evaluation of Clareon PanOptix Pro ...Study Plan ; Experimental : Clareon PanOptix Pro/Pro Toric Trifocal IOL. The clouded lens will be removed by phacoemulsification, after which the PanOptix Pro ...
The Clareon Vs AcrySof PanOptix Trifocal IOLSignificantly more AcrySof (66%) than Clareon (42%) patients achieved a spherical equivalent outcome within 0.25 D of target. Best corrected ...
Functional Outcomes After Refractive Lens Exchange With ...There is as yet scarce clinical data on the Clareon. PanOptix IOL, as it is relatively new. Lee et al. retrospec- tively examined outcomes after ...
Functional Outcomes After Refractive Lens Exchange With ...In a retrospective study of RLE patients implanted with the AcrySof IQ PanOptix Toric IOL Wallerstein et al found 87% of them achieved 20/20 binocular UDVA, ...
Clareon® PanOptix® Pro Trifocal IOL | Alcon Professional USFor the Clareon® PanOptix® Pro Toric Trifocal IOLs, the lens should not be implanted if the posterior capsule is ruptured, if the zonules are damaged, or if a ...
A Complete Guide to the PanOptix IOLFor patients having cataract surgery or custom lens replacement, this is one ... The following are safety data from the FDA's clinical trial: Source ...
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