Cataract
Conditions
Keywords
intraocular lens, LAL+, Clareon Vivity Toric IOLs
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.
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.
Sponsors
The Eye Associates
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Binocular photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm |
Countries
United States
Contacts
Primary ContactCathleen McCabe, MD
Backup ContactAlisha Polson
Outcome results
None listed