Visual Acuity Outcome Differences Between the Alcon Vivity Toric IOL and RxSight LAL+
Starting soon · Not applicable
Conditions studied: Cataract
In brief
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 facts
- Study ID
- NCT06574646
- Run by
- The Eye Associates
- People needed
- 250
- Starts
- 2024-10-15
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2024-08-28
Who can join
Age: 45 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
You may not qualify if…
- 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.
Where it is running
- The Eye Associates of Manatee, LLP — Bradenton, Florida, United States
Full record on ClinicalTrials.gov
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