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NCT Number: NCT06574646

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

Phase 1 will be ambispective, multi-site, single arm study in age-related cataract patients with regular astigmatism, who were bilaterally treated with the LAL+ IOLs

Phase 2 will be a prospective, randomized, unmasked, comparative, multi-site study with 90 days of follow up. Subjects will be randomized in a 1:1 manner to LAL+ or Clareon VIvity Toric IOLs.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Eye Associates of Manatee, LLP

Bradenton, Florida, 34209, United States

Location contact

Cathleen McCabe, MD

PRINCIPAL_INVESTIGATOR

Matthew Pippin

CONTACT

[email protected]

941-220-5987

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

LAL+

Device

LAL+ IOL allows for refractive error (both sphere and cylinder) enhancements post-IOL implantation by exposing the IOL to ultraviolet (UV) light through a series of noninvasive treatments with a Light Delivery Device.

Clareon Vivity Toric IOL

Device

Clareon Vivity Toric IOL utilizes an extended depth of focus (EDOF) design, which incorporates nondiffractive wavefront shaping (X-WAVE) technology.

Primary outcomes

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

    Time frame: 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.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Alisha Polson

CONTACT

941-220-5987

Cathleen McCabe, MD

CONTACT

[email protected]

941-220-5987

Sponsors and collaborators

Lead sponsor

The Eye Associates

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 28, 2024
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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