Visual Acuity Outcome Differences Between the Alcon Vivity Toric IOL and RxSight LAL+
The Eye Associates
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.
Eligibility
- Age range
- 45+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceLAL+
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.
- DeviceClareon Vivity Toric IOL
Clareon Vivity Toric IOL utilizes an extended depth of focus (EDOF) design, which incorporates nondiffractive wavefront shaping (X-WAVE) technology.
Location
- The Eye Associates of Manatee, LLPBradenton, Florida