CataractNCT07076277
Visual Outcomes in Patients Contralaterally Implanted With PanOptix Pro and Clareon Vivity Compared to Bilateral Implantation of PanOptix Pro
A study testing Clareon PanOptix Pro and Clareon Vivity Intraocular Lens and Clareon PanOptix Pro Intraocular Lenses in people with Cataract and Multifocal Intraocular Lens, run by Brian Shafer at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Multifocal Intraocular Lens
- What is being tested?
- Clareon PanOptix Pro and Clareon Vivity Intraocular Lens and Clareon PanOptix Pro Intraocular Lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- 5 sitesUnited States
- Study dates
- 5 Aug 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites
Vance Thompson Vision
Alexandria, Minnesota, 56308
Main Line Surgery Center
Bala-Cynwyd, Pennsylvania, 19004
VIP Eye Care
Baltimore, Maryland, 21286
Vance Thompson Vision
Bozeman, Montana, 59718
Shafer Vision Institute
Plymouth Meeting, Pennsylvania, 19462
About this study
Title:
Visual Outcomes in Patients Contralaterally Implanted with PanOptix Pro and Clareon Vivity Compared to Bilateral Implantation of PanOptix Pro
Read more
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
Read the 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
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
- Conditions
- Cataract, Multifocal Intraocular Lens
- Being tested
- Clareon PanOptix Pro and Clareon Vivity Intraocular Lens, Clareon PanOptix Pro Intraocular Lenses
- Keywords
- multifocal intraocular lens, cataract, cataract surgery, Presbyopia Correcting IOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clareon PanOptix Pro and Clareon Vivity Intraocular LensDevice
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 LensesDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Clareon PanOptix Pro Intraocular Lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months post-operative visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start5 Aug 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 346 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brian Shafer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brian Shafer, Shafer Vision Institute
- Investigators
- Brian Shafer, MD, Principal investigator, Shafer Vision Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076277
- Sponsor's protocol ID
- SVI-POPCV-001
- Status last verified
- Sep 2025
- First submitted
- 14 Jul 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Not applicable; individual participant-level data will not be shared.
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.
PubMed 35082481Arrigo 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.
PubMed 34050809Sudhir 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.
PubMed 31403494
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Outcomes in Patients Contralaterally Implanted With PanOptix Pro and Clareon Vivity Compared to Bilateral Implantation of PanOptix Pro
- ClinicalTrials.gov ID
- NCT07076277
- Acronym / sponsor ID
- SVI-POPCV-001
- Conditions
- Cataract, Multifocal Intraocular Lens
- Keywords
- multifocal intraocular lens, cataract, cataract surgery, Presbyopia Correcting IOL
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 346 participants (estimated)
- Lead sponsor
- Brian ShaferUniversity, hospital or other
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contralateral PanOptix Pro and Clareon Vivity | Experimental | Device: Clareon PanOptix Pro and Clareon Vivity Intraocular LensSubjects 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. |
| Bilateral PanOptix Pro | Active comparator | Device: Clareon PanOptix Pro Intraocular LensesSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clareon PanOptix Pro and Clareon Vivity Intraocular LensBilateral 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 | Contralateral PanOptix Pro and Clareon Vivity |
| Clareon PanOptix Pro Intraocular LensesBilateral 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. | Device | Bilateral PanOptix Pro |
Primary outcome
Binocular Best-Corrected Distance Visual Acuity (BCDVA) at 4 meters
Time frame: 3 months post-operative visit
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Results publication: PubMed 35082481Hovanesian 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.
- Results publication: PubMed 34050809Arrigo 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.
- Results publication: PubMed 31403494Sudhir 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.
- Individual participant dataSharing planned: No. Not applicable; individual participant-level data will not be shared.
Related trials for Cataract
RecruitingObservational study
Capella Scientia Development Study
Cataract
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brian Shafer, MD principal investigator
Shafer Vision Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clareon PanOptix Pro and Clareon Vivity Intraocular Lens and Clareon PanOptix Pro Intraocular Lenses in people with Cataract and Multifocal Intraocular Lens, run by Brian Shafer at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binocular Best-Corrected Distance Visual Acuity (BCDVA) at 4 meters (time frame: 3 months post-operative visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07076277, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.