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

Part of paid clinical trials in Bradenton, Florida.

Sponsor
The Eye Associates
Study ID
NCT06574646
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Cataract

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Oct 15, 2024
Status verified
Aug 2024
Primary completion
Feb 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LAL+
  • Active Comparator: Clareon Vivity Toric IOLs

Primary Outcome Measure

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Eye Associates of Manatee, LLPBradentonFlorida34209
Matthew Pippin
[email protected]
941-220-5987
Cathleen McCabe, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Bradenton, FL

By research site
The Eye Associates of Manatee, LLP· Bradenton, FL

Related Studies