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
Subjects will have an expected monocular BCDVA outcomes of 20/25 or better in the opinion of the investigator
My eye condition can be corrected with a specific lens for astigmatism.
Subjects will be required to have a dilated pupil diameter of 7 mm or greater in both eyes
+2 more
Exclusion Criteria
I have severe dry eye condition.
Irregular astigmatism
I have a history of glaucoma.
+11 more
Participant Groups
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