Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
This trial is for adults with age-related cataracts and regular astigmatism who have not yet had surgery. Participants must be suitable for bilateral implantation of LAL+ IOLs in Phase 1, or willing to be randomly assigned to receive either LAL+ or Clareon Vivity Toric IOLs in Phase 2.Inclusion Criteria
I am over 45, have astigmatism, and need cataract surgery in both eyes.
My eye surgery aims for perfect or near-perfect vision.
Exclusion Criteria
I have a history of glaucoma.
I have severe dry eye condition.
I have a serious eye condition affecting my cornea.
I have a history of involuntary eye movements.
I have had eye surgery or plan to have eye surgery.
I have an eye condition that may cause future vision loss.
My eye's lens is not properly supported.
I have a history of pseudoexfoliation.
I am on medication that increases my sensitivity to sunlight or could harm my eyes.
Treatment Details
The study examines visual outcomes using two types of lens implants after cataract surgery: the RxSight LAL+ and Alcon's Clareon Vivity Toric IOL. Phase 1 observes patients with LAL+, while Phase 2 compares both lenses over a period of three months.
2Treatment groups
Experimental Treatment
Active Control
Group I: LAL+Experimental Treatment1 Intervention
Group II: Clareon Vivity Toric IOLsActive Control1 Intervention
Find a clinic near you
Research locations nearbySelect from list below to view details:
The Eye Associates of Manatee, LLPBradenton, FL
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Who is running the clinical trial?
The Eye AssociatesLead Sponsor