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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Brian Shafer
Study ID
NCT07076277
Status
Enrolling By Invitation

Conditions

  • Cataract
  • Multifocal Intraocular Lens

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Clareon PanOptix Pro and Clareon Vivity Intraocular Lens — DEVICE
    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
  • Clareon PanOptix Pro Intraocular Lenses — DEVICE
    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.

Study Details

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

Key Dates

Start date
Aug 5, 2025
Status verified
Sep 2025
Primary completion
Aug 1, 2026
Completion
Dec 1, 2026

Study Design

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

Arms

  • Experimental: Contralateral PanOptix Pro and Clareon Vivity
    Subjects randomized to this arm will receive bilateral cataract surgery with contralateral implantation: Alcon Clareon PanOptix Pro or PanOptix Pro Toric IOL in one eye and Alcon Clareon Vivity or Vivity Toric IOL in the fellow eye. The Vivity IOL will be implanted in the dominant eye, with all surgeries targeting emmetropia. Residual astigmatism will be managed to ≤0.50 diopters using toric IOLs or arcuate incisions as needed.
  • Active Comparator: Bilateral PanOptix Pro
    Subjects randomized to this arm will receive bilateral cataract surgery with implantation of Alcon Clareon PanOptix Pro or PanOptix Pro Toric IOLs in both eyes. All eyes will be targeted for emmetropia, and residual astigmatism will be controlled to ≤0.50 diopters using toric IOLs or arcuate incisions as appropriate.

Primary Outcome Measure

Binocular Best-Corrected Distance Visual Acuity (BCDVA) at 4 meters [ Time Frame: 3 months post-operative visit ]

Locations (5)

FacilityCityStateZIPSite coordinators
VIP Eye CareBaltimoreMaryland21286-
Vance Thompson VisionAlexandriaMinnesota56308-
Vance Thompson VisionBozemanMontana59718-
Main Line Surgery CenterBala-CynwydPennsylvania19004-
Shafer Vision InstitutePlymouth MeetingPennsylvania19462-

Find similar trials in Baltimore, MD

By research site
VIP Eye Care· Baltimore, MDVance Thompson Vision· Alexandria, MNVance Thompson Vision· Bozeman, MTMain Line Surgery Center· Bala-Cynwyd, PAShafer Vision Institute· Plymouth Meeting, PA

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