Visual Acuity Outcome Differences Between the Alcon Vivity Toric IOL and RxSight LAL+ (NCT06574646) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Visual Acuity Outcome Differences Between the Alcon Vivity Toric IOL and RxSight LAL+
United States250 participantsStarted 2024-10-15
Plain-language 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.
Who can participate
Age range
45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Binocular photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm
Timeframe: 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.