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

NCT06574646 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: A126-101
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cataract

Keywords

intraocular lens; LAL+; Clareon Vivity Toric IOLs

Outcome Measures

Primary Outcomes (1)

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

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

  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.

Study Arms (2)

LAL+

EXPERIMENTAL

Device: LAL+

Clareon Vivity Toric IOLs

ACTIVE COMPARATOR

Device: Clareon Vivity Toric IOL

Interventions

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.

LAL+

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.

Clareon Vivity Toric IOLs

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Eye Associates: lead

Study Sites (1)

The Eye Associates of Manatee, LLP

Bradenton, Florida, 34209, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Cathleen M McCabe, MD

  The Eye Associates of Manatee

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cathleen McCabe, MD

CONTACT

941-220-5987; cmccabe13@hotmail.com

Alisha Polson

CONTACT

941-220-5987

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 28, 2024
• Study Start: October 15, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

US (1)