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

The Eye Associates

Status

Not yet enrolling

Conditions

Cataract

Treatments

Device: LAL+

Device: Clareon Vivity Toric IOL

Study type

Interventional

Funder types

Other

Identifiers

NCT06574646

A126-101

Details and patient eligibility

About

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.

Enrollment

250 estimated patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

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.