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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cataract
• Intervention / Treatment: Device: LAL+; Device: Clareon Vivity Toric IOL

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cathleen McCabe, MD; Phone Number: 941-220-5987; Email: cmccabe13@hotmail.com
• Study Contact Backup: Name: Alisha Polson; Phone Number: 941-220-5987

Study Locations

• United States
  • Florida
    • Bradenton, Florida, United States, 34209
      • The Eye Associates of Manatee, LLP
      • Principal Investigator: Cathleen McCabe, MD
      • Contact: Matthew Pippin; Phone Number: 941-220-5987; Email: mpippin@theeyeassociates.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LAL+	Device: LAL+; 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.
Active Comparator: Clareon Vivity Toric IOLs	Device: Clareon Vivity Toric IOL; Clareon Vivity Toric IOL utilizes an extended depth of focus (EDOF) design, which incorporates nondiffractive wavefront shaping (X-WAVE) technology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: The Eye Associates
• Investigators: Principal Investigator: Cathleen M McCabe, MD, The Eye Associates of Manatee

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: August 9, 2024
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: intraocular lens; LAL+; Clareon Vivity Toric IOLs
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: A126-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No