A Prospective, Randomized, Subject and Vision-assessor Masked, Multicenter Study Comparing Bilateral Clareon PanOptix, Bilateral Clareon PanOptix Pro, and Mixed Clareon PanOptix Pro/Vivity Intraocular Lens Implantation in Cataract Subjects
Berkeley Eye Center
Summary
Prospective, randomized, multicenter, multi-arm, subject and vision-assessor-masked, two stage study with Stage 1 as a three-arm initial enrollment period, followed by Stage 2 as a head-to-head study refined based on the Stage 1 data.
Eligibility
- Age range
- 40+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Adult cataract patients aged 40 years and older scheduled for age related cataract surgery in both eyes. * Ability to understand and sign an ethics committee-approved informed consent form. * Willingness and ability to attend all scheduled study visits as required by the protocol. * Postoperative potential visual acuity of 20/25 or better in each eye, as determined by the investigator. * Preoperative corneal astigmatism that can be corrected with a T3 or T4 toric IOL, or with a spherical IOL and LRIs or AKs resulting in a predicted postoperative astigmatism of less than…
Interventions
- DeviceClareon PanOptix
Bilateral Clareon PanOptix IOL implantation
- DrugClareon PanOptix PRO
Bilateral Clareon PanOptix PRO IOL implantation
- DrugMix-and-Match PanOptix/Vivity
Clareon PanOptix Pro in the non-dominant eye and Clareon Vivity in the dominant eye
Locations (2)
- Shafer Vision InstitutePlymouth Meeting, Pennsylvania
- Berkeley Eye CenterHouston, Texas