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

NCT07076277 | Enrolling By Invitation FDA Device

• 1 other identifier: SVI-POPCV-001
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 5

Brief 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

Conditions

Cataract; Multifocal Intraocular Lens

Keywords

multifocal intraocular lens; cataract; cataract surgery; Presbyopia Correcting IOL

Outcome Measures

Primary Outcomes (1)

• Binocular Best-Corrected Distance Visual Acuity (BCDVA) at 4 meters

  Binocular BCDVA measured in logMAR under photopic conditions (85 cd/m²) at 4 m using standardized ETDRS charts with the M\&S Clinical Trial Suite (CTS). Non-inferiority margin of 0.1 logMAR between treatment arms.

  3 months post-operative visit

Study Arms (2)

Contralateral PanOptix Pro and Clareon Vivity

EXPERIMENTAL

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.

Device: Clareon PanOptix Pro and Clareon Vivity Intraocular Lens

Bilateral PanOptix Pro

ACTIVE COMPARATOR

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.

Device: Clareon PanOptix Pro Intraocular Lenses

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

Contralateral PanOptix Pro and Clareon Vivity

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.

Bilateral PanOptix Pro

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Brian Shafer: lead

Study Sites (5)

VIP Eye Care

Baltimore, Maryland, 21286, United States

Location

Vance Thompson Vision

Alexandria, Minnesota, 56308, United States

Location

Vance Thompson Vision

Bozeman, Montana, 59718, United States

Location

Main Line Surgery Center

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Shafer Vision Institute

Plymouth Meeting, Pennsylvania, 19462, United States

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Brian Shafer, MD

  Shafer Vision Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking: Double (Participant, Outcomes Assessor) Masking Description: Subjects and outcomes assessors will be blinded to IOL assignments to reduce bias in patient-reported outcomes and visual acuity testing. Surgeons are unmasked for implantation procedures but do not participate in postoperative assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ophthalmologist

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 22, 2025
• Study Start: August 5, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)