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

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

SVI-POPCV-001 Protocol Detailed Description Title: Visual Outcomes in Patients Contralaterally Implanted with PanOptix Pro and Clareon Vivity Compared to Bilateral Implantation of PanOptix Pro Sponsor and Investigator Brian Shafer, MD Shafer Vision Institute, USA Study Phase: Investigator-Initiated Trial (IIT) RTI#: 25-IL73, IIT Proposal #97074289 Protocol Version 1.0 (21 May 2025) Study Objective To evaluate visual outcomes and patient-reported satisfaction in patients with bilateral age-related cataracts randomized to either: Contralateral implantation (PanOptix Pro in one eye and Clareon Vivity in the other) Bilateral PanOptix Pro implantation Hypotheses: Contralateral approach will be non-inferior in binocular BCDVA at 4 m. Contralateral approach will yield superior outcomes in reducing visual disturbances like halos. Study Design Prospective, randomized, double-masked, two-arm, multicenter trial 5 surgeons at 4 sites N=346 subjects (173 per arm), powered for 80% with 10% dropout buffer Randomized 1:1 Arm 1: PanOptix Pro (dominant eye) + Clareon Vivity (non-dominant eye) Arm 2: Bilateral PanOptix Pro All surgeries target emmetropia Surgical Methods Bilateral phacoemulsification Optional femtosecond laser-assisted cataract surgery Second eye surgery within 4 weeks Residual astigmatism ≤0.50 D, managed with toric IOLs or arcuate incisions Preoperative IOL calculation using Barrett Universal II and Barrett Toric Calculator Toric alignment via ORA, Veracity, or digital/femtosecond laser marking Biometry with ARGOS, IOLMaster 700, Lenstar HOA/coma measurement with topography (Cassini, Pentacam, iTrace, Atlas) Assessment Tools M\&S Clinical Trial Suite (CTS) for standardized VA testing Validated questionnaires (IOLSAT, QUVID) for patient-reported outcomes Measurements: Photopic \& mesopic VA Defocus curves Contrast sensitivity with/without glare Manifest refraction Masking: Subjects and outcome assessors blinded to IOL assignment Endpoints Primary Endpoint (3 months): Binocular best-corrected distance VA (BCDVA) at 4 m Secondary Endpoints (3 months): Binocular DCIVA at 66 cm DCNVA at 40 cm and 33 cm UDVA, UIVA, UNVA at the same distances Defocus curves over ±3.00 D range Refractive outcomes (sphere, cyl, MRSE) Visual disturbance scores via QUVID Exploratory: Mesopic VA Photopic low-contrast VA Mesopic contrast sensitivity (with/without glare) Patient satisfaction via IOLSAT Eligibility Inclusion: Adults with bilateral age-related cataracts Suitable for bilateral phacoemulsification Post-op monocular BCDVA expected ≤0.1 logMAR (20/25) Residual astigmatism ≤0.50 D Normal ocular exam except cataract Exclusion: Corneal pathology or irregular astigmatism Retinal disease, macular degeneration, glaucoma Severe dry eye, nystagmus, strabismus Zonular instability or pseudoexfoliation Prior ocular surgery (including refractive) Monovision preference Amblyopia or monofixation HOA \>0.6 um Combined procedures planned Participation in conflicting trials Pregnancy/breastfeeding Statistical Analysis Non-inferiority margin: 0.1 logMAR Step-down analysis order: BCDVA (non-inferiority) DCIVA (non-inferiority) DCNVA 33 cm (superiority) Visual disturbance rates (superiority) 5-9. Other VA measures (non-inferiority/superiority) Alpha = 0.05 Two-proportion Z-test for visual disturbances t-tests or Wilcoxon tests depending on distribution Defocus curve comparisons via 2-way ANOVA Sample Size Justification: Powered for BCDVA difference of 0.05 logMAR with SD 0.15 Minimum \~250 needed accounting for dropout Cap of \~70 subjects per surgeon, adjustable with approval Adverse Event Management AEs: any abnormal ocular signs/symptoms SAEs include death, life-threatening events, hospitalization, disability, congenital anomalies Adverse Device Effects: linked to IOL or surgical process Severity grading: mild, moderate, severe (not same as SAE) Investigator assessment of relationship (not/possibly/probably/definitely related) Immediate reporting of SAEs/ADEs to sponsor/IRB Protocol deviations documented and reported per IRB policy Data Handling Data de-identified with subject numbers Source documents secured physically and digitally Strict confidentiality per law ClinicalTrials.gov registration IRB oversight for amendments, AE/SAE reports, study closure Confidentiality and Regulatory Compliance Results may be published without identifying participants Data shared with sponsor, regulatory agencies, IRB Conducted per protocol, GCP, and applicable laws