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

Overview

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

Detailed description

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

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.

Primary outcome measures

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

Eligibility criteria

Inclusion Criteria Adult patients (≥18 years old) able and willing to provide informed consent.

Bilateral diagnosis of age-related cataracts.

Planned bilateral cataract removal by phacoemulsification with either:

Contralateral implantation of Clareon PanOptix Pro/PanOptix Pro Toric in one eye and Clareon Vivity/Vivity Toric in the fellow eye, or

Bilateral implantation of Clareon PanOptix Pro/PanOptix Pro Toric.

Expected best monocular corrected distance visual acuity (BCDVA) of 0.1 logMAR (Snellen 20/25) or better in both eyes postoperatively, as determined by the surgeon.

Residual astigmatism expected to be ≤0.50 diopters in both eyes postoperatively (using toric IOLs or arcuate incisions as needed).

Normal ocular findings aside from cataracts.

Exclusion Criteria Corneal pathology or irregular astigmatism.

Preexisting macular disease or other retinal degenerative disease expected to cause vision loss.

Glaucoma.

Severe dry eye disease.

Nystagmus or strabismus.

Zonular laxity or dehiscence, pseudoexfoliation.

Any condition (in the investigator's opinion) that may affect study endpoints.

Previous history of any ocular surgery, including corneal refractive surgery.

Subjects desiring monovision.

History of amblyopia or monofixation syndrome with poor stereoscopic vision.

Total corneal higher-order aberrations (HOA) greater than 0.6 microns.

Any planned simultaneous or combined procedures at the time of cataract surgery (e.g., MIGS).

Participation in another clinical study that could interfere with study results.

Any active ocular infection or inflammation.

Pregnant, breastfeeding, or planning to become pregnant during the study (as determined by verbal inquiry).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 5 centers

• VIP Eye Care — Baltimore
• Vance Thompson Vision — Alexandria
• Vance Thompson Vision — Bozeman
• Main Line Surgery Center — Bala-Cynwyd
• Shafer Vision Institute — Plymouth Meeting

Publications

• Hovanesian JA, Jones M, Allen Q. The Vivity Extended Range of Vision IOL vs the PanOptix Trifocal, ReStor 2.5 Active Focus and ReStor 3.0 Multifocal Lenses: A Comparison of Patient Satisfaction, Visual Disturbances, and Spectacle Independence. Clin Ophthalmol. 2022 Jan 18;16:145-152. doi: 10.2147/OPTH.S347382. eCollection 2022. PMID 35082481
• Arrigo A, Gambaro G, Fasce F, Aragona E, Figini I, Bandello F. Extended depth-of-focus (EDOF) AcrySof(R) IQ Vivity(R) intraocular lens implant: a real-life experience. Graefes Arch Clin Exp Ophthalmol. 2021 Sep;259(9):2717-2722. doi: 10.1007/s00417-021-05245-6. Epub 2021 May 29. PMID 34050809
• Sudhir RR, Dey A, Bhattacharrya S, Bahulayan A. AcrySof IQ PanOptix Intraocular Lens Versus Extended Depth of Focus Intraocular Lens and Trifocal Intraocular Lens: A Clinical Overview. Asia Pac J Ophthalmol (Phila). 2019 Jul-Aug;8(4):335-349. doi: 10.1097/APO.0000000000000253. PMID 31403494

Identifiers

NCT: NCT07076277 · SVI-POPCV-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗