By InvitationNot Applicable

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

United States346 participantsStarted 2025-08-05

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 cl…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 3 months post-operative visit

Trial details

NCT IDNCT07076277

SponsorBrian Shafer

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-01

View on ClinicalTrials.gov More Cataract trials