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