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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
Full 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
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
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion 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).
Primary purpose
Allocation
Interventional model
Masking
346 participants in 2 patient groups
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Central trial contact
Brian Shafer, MD
Data sourced from clinicaltrials.gov
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