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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: t
View:

• 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 0.5 diopters (D).

• Ability to understand and complete questionnaires.

Locations
United States
Pennsylvania
Shafer Vision Institute
RECRUITING
Plymouth Meeting
Texas
Berkeley Eye Center
RECRUITING
Houston
Contact Information
Primary
Tetiana Huff
tetiana.huff@berkeleyeye.com
713-620-7640
Time Frame
Start Date: 2025-03-17
Estimated Completion Date: 2026-04
Participants
Target number of participants: 320
Treatments
Active_comparator: Bilateral Clareon PanOptix IOL implantation
Experimental: Bilateral Clareon PanOptix Pro IOL implantation
Experimental: Clareon PanOptix Pro in the non-dominant eye and Clareon Vivity in the dominant eye
Related Therapeutic Areas
Sponsors
Leads: Berkeley Eye Center
Collaborators: Sengi

This content was sourced from clinicaltrials.gov