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