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Visual Acuity Outcomes with Alcon Vivity Toric IOL vs. RxSight LAL+ for Cataracts

This study is comparing two types of intraocular lenses (IOLs) for people with cataracts and astigmatism (a common vision problem). One is the RxSight LAL+ IOL, which can be adjusted after surgery using UV light to fine-tune your vision. The other is the Clareon Vivity Toric IOL, which uses a special design to provide a wider range of clear vision. The study aims to see which IOL provides better intermediate vision (like for computer use) after surgery. You may be eligible if you are at least 45 years old, need cataract surgery in both eyes, and have astigmatism. The study is currently recruiting participants.

Study design
This study has two phases. Phase 1 is a single-arm study, and Phase 2 is a prospective, randomized, unmasked, comparative study where participants are randomly assigned to receive either the LAL+ or Clareon Vivity Toric IOL. The planned enrollment is 250 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed up for 90 days after surgery, or at least one week after final adjustments for LAL+ IOLs.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06574646

Visual Acuity Outcome Differences Between the Alcon Vivity Toric IOL and RxSight LAL+

Not Yet Recruiting
NAAges 45+InterventionalTreatment
The Eye Associates
~250 participants
Updated 2024-08-28 on ClinicalTrials.gov
What's tested:LAL+Clareon Vivity Toric IOL

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Binocular photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm
Measured over 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.

Conditions

Cataract

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Cataract

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Cathleen M McCabe, MD · PRINCIPAL_INVESTIGATOR · The Eye Associates of Manatee

Who to contact

Cathleen McCabe, MD
[email protected]
941-220-5987
Email the study team

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Eligibility criteria

Inclusion

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);
Subjects will have an expected monocular BCDVA outcomes of 20/25 or better in the opinion of the investigator;
Subjects will have regular corneal astigmatism (1.00 to 2.00 D), which can be corrected with a toric power IOL of T3-T5;
Subjects will be required to have a dilated pupil diameter of 7 mm or greater in both eyes;

Exclusion

Moderate-severe corneal pathology;
Irregular astigmatism;
Subject desire monovision correction;
Preexisting macular disease or other retinal degenerative diseases that is expected to cause future vision loss;
History of glaucoma;
Severe dry eye disease;
History of uveitis;
History of ocular herpes simplex virus;
History of nystagmus;
Zonular laxity or dehiscence;
History psueudoexfoliation;
History of corneal refractive and intraocular surgery or requiring any other planned ocular surgical procedures;
Currently taking systemic medication that may increase sensitivity to UV light or that may cause toxicity to the retina;
Pregnant or breastfeeding.

What this trial measures

  • Binocular photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cmat 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.

    Binocular photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm