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Intraocular Lens

Clareon Vivity Toric IOL vs LAL+ for Cataracts

N/A

Waitlist Available

Led By Cathleen M McCabe, MD

Research Sponsored by The Eye Associates

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult (≥45) subjects who are astigmatic and require bilateral, routine small-incision surgery for age-related cataracts with femtosecond laser

All subjects will be required to be targeted for refractive emmetropia (plano or first minus closest to plano)

Must not have

History of glaucoma

Severe dry eye disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the 90-day post-op visit or at least 1 week after final lock-in if longer than 3 months for lal+ implanted subjects and >2 weeks post yag, if done.

Awards & highlights

No Placebo-Only Group

Summary

This trial will involve two phases. Phase 1 will look at cataract patients with astigmatism who will receive treatment with LAL+ IOLs. Phase 2 will be a study

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort, redness, inflammation, blurry vision post-surgery, halos around lights at night, and other visual disturbances typically associated with eye surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 45, have astigmatism, and need cataract surgery in both eyes.

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My eye surgery aims for perfect or near-perfect vision.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of glaucoma.

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I have severe dry eye condition.

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I have a serious eye condition affecting my cornea.

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I have a history of involuntary eye movements.

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I have had eye surgery or plan to have eye surgery.

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I have an eye condition that may cause future vision loss.

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My eye's lens is not properly supported.

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I have a history of pseudoexfoliation.

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I am on medication that increases my sensitivity to sunlight or could harm my eyes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the 90-day post-op visit or at least 1 week after final lock-in if longer than 3 months for lal+ implanted subjects and >2 weeks post yag, if done.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the 90-day post-op visit or at least 1 week after final lock-in if longer than 3 months for lal+ implanted subjects and >2 weeks post yag, if done.

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the 90-day post-op visit or at least 1 week after final lock-in if longer than 3 months for lal+ implanted subjects and >2 weeks post yag, if done. for reporting.