Not yet recruiting NCT06574646
Visual Acuity Outcome Differences Between the Alcon Vivity Toric IOL and RxSight LAL+
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LAL+, Clareon Vivity Toric IOL.
- Who it may be relevant to
- Registry conditions: Cataract. Basic parameters: from 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- 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. - 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.
Primary outcome measures
- 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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The Eye Associates of Manatee, LLP — Bradenton
Identifiers
NCT: NCT06574646 · A126-101