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

Part of paid clinical trials in Plymouth Meeting, Pennsylvania.

Sponsor
Berkeley Eye Center
Study ID
NCT06922084
Phase
PHASE4
Status
Recruiting
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Conditions

  • Cataract

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Clareon PanOptix — DEVICE
    Bilateral Clareon PanOptix IOL implantation
  • Clareon PanOptix PRO — DRUG
    Bilateral Clareon PanOptix PRO IOL implantation
  • Mix-and-Match PanOptix/Vivity — DRUG
    Clareon PanOptix Pro in the non-dominant eye and Clareon Vivity in the dominant eye

Study Details

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.

Key Dates

Start date
Mar 17, 2025
Status verified
Apr 2025
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
320 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Binocular photopic CDVA (corrected distance visual acuity) [ Time Frame: 3 months postoperatively ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Shafer Vision InstitutePlymouth MeetingPennsylvania19462
Brian Shafer (PRINCIPAL_INVESTIGATOR)
Berkeley Eye CenterHoustonTexas77027
Tetiana Huff
[email protected]
713-620-7640
Morgan Micheletti, MD (PRINCIPAL_INVESTIGATOR)

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