Visual Outcomes in Patients Contralaterally Implanted With PanOptix Pro and Clareon Vivity Compared to Bilateral Implantation of PanOptix Pro

Summary

Title:

Visual Outcomes in Patients Contralaterally Implanted with PanOptix Pro and Clareon Vivity Compared to Bilateral Implantation of PanOptix Pro

Sponsor:

Brian Shafer, MD, Shafer Vision Institute

Objective:

To compare visual outcomes and patient-reported satisfaction in cataract patients receiving either:

Contralateral implantation (PanOptix Pro in one eye, Clareon Vivity in the other)

Bilateral PanOptix Pro implants

Key hypotheses:

Contralateral implantation is non-inferior for binocular best-corrected distance visual acuity (BCDVA) at 4 m.

Contralateral implantation yields superior visual disturbance outcomes (less halo, glare, starburst).

Design:

Prospective, randomized, double-masked, two-arm, multicenter study

N = 346 subjects (173 per arm)

5 surgeons across 4 sites

All patients undergo bilateral phacoemulsification aiming for emmetropia

Randomized 1:1 to:

Arm 1: PanOptix Pro (dominant eye) + Clareon Vivity (non-dominant eye)

Arm 2: Bilateral PanOptix Pro

Surgical Details:

Femtosecond laser optional

Second eye surgery ≤4 weeks after first

Toric IOLs or arcuate incisions for residual astigmatism ≤0.50 D

Biometry with ARGOS, IOLMaster 700, or Lenstar

Toric alignment with ORA, Callisto, etc.

Assessments:

Visual acuity at 4 m, 66 cm, 40 cm, 33 cm in photopic and mesopic conditions

Defocus curves, contrast sensitivity (with/without glare)

Manifest refraction

Patient-reported outcomes via IOLSAT and QUVID questionnaires

Masking: subjects and assessors unaware of IOL assignments

Endpoints (at 3 months):

Primary: Binocular BCDVA (4 m)

Secondary: DCIVA, DCNVA, UDVA, UIVA, UNVA, defocus curves, refractive outcomes, visual disturbance scores

Exploratory: Mesopic VA, low contrast VA, contrast sensitivity, satisfaction scores

Eligibility Criteria:

Adults with bilateral age-related cataracts

Plan for bilateral phacoemulsification

Expected postop monocular BCDVA ≤0.1 logMAR (20/25)

Residual astigmatism ≤0.50 D

Exclusions include corneal pathology, macular disease, glaucoma, prior ocular surgery, amblyopia, severe dry eye, high HOA (\>0.6 um), monovision preference, active infection/inflammation, pregnancy

Statistics:

Non-inferiority margin: 0.1 logMAR

Superiority testing for visual disturbances

Step-down testing hierarchy for primary and secondary outcomes

Sample size powered for 80% at α=0.05, accounting for 10% dropout

Two-proportion Z-tests for dysphotopsia rates

Safety Monitoring:

Adverse Events (AEs) and Serious Adverse Events (SAEs) captured

Definitions, severity grading, and reporting procedures specified

Protocol deviations documented and reported per IRB requirements

Data Handling:

Data anonymized via subject numbers

Stored securely (locked cabinets, password-protected systems)

Study registered at ClinicalTrials.gov

Visit Schedule:

Screening: Consent, eligibility, history

1st \& 2nd Eye Surgery Visits

3-Month Post-Op Visit: Comprehensive visual assessments, questionnaires, AE review

Conditions

• Cataract
• Multifocal Intraocular Lens

Interventions

DEVICE

Clareon PanOptix Pro and Clareon Vivity Intraocular Lens

Bilateral cataract surgery with contralateral implantation: Alcon Clareon PanOptix Pro (or PanOptix Pro Toric) intraocular lens in one eye and Alcon Clareon Vivity (or Vivity Toric) intraocular lens i

DEVICE

Clareon PanOptix Pro Intraocular Lenses

Bilateral cataract surgery with implantation of Alcon Clareon PanOptix Pro (or PanOptix Pro Toric) intraocular lenses in both eyes. All surgeries target emmetropia with residual astigmatism ≤0.50 diopters using toric IOLs or arcuate incisions as needed.

Sponsors & Collaborators

• Brian Shafer

  lead OTHER

Principal Investigators

• Brian Shafer, MD · Shafer Vision Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-05

Primary Completion

2026-08-01

Completion

2026-12-01

FDA Device

Yes

Countries

• United States

Study Locations