[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07076277":3,"trial-entities:NCT07076277":117,"trial-summary:NCT07076277":120},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":44,"secondary_outcomes":49,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":14,"eligibility_criteria":53,"std_ages":57,"locations":60,"central_contacts":100,"overall_officials":101,"references":105,"see_also_links":116},"NCT07076277","SVI-POPCV-001","Visual Outcomes in Patients Contralaterally Implanted With PanOptix Pro and Clareon Vivity Compared to Bilateral Implantation of PanOptix Pro","ENROLLING_BY_INVITATION","2026-12-01","2025-09","2025-09-22","2025-08-05","Brian Shafer","OTHER",false,"Title:\n\nVisual Outcomes in Patients Contralaterally Implanted with PanOptix Pro and Clareon Vivity Compared to Bilateral Implantation of PanOptix Pro\n\nSponsor:\n\nBrian Shafer, MD, Shafer Vision Institute\n\nObjective:\n\nTo compare visual outcomes and patient-reported satisfaction in cataract patients receiving either:\n\nContralateral implantation (PanOptix Pro in one eye, Clareon Vivity in the other)\n\nBilateral PanOptix Pro implants\n\nKey hypotheses:\n\nContralateral implantation is non-inferior for binocular best-corrected distance visual acuity (BCDVA) at 4 m.\n\nContralateral implantation yields superior visual disturbance outcomes (less halo, glare, starburst).\n\nDesign:\n\nProspective, randomized, double-masked, two-arm, multicenter study\n\nN = 346 subjects (173 per arm)\n\n5 surgeons across 4 sites\n\nAll patients undergo bilateral phacoemulsification aiming for emmetropia\n\nRandomized 1:1 to:\n\nArm 1: PanOptix Pro (dominant eye) + Clareon Vivity (non-dominant eye)\n\nArm 2: Bilateral PanOptix Pro\n\nSurgical Details:\n\nFemtosecond laser optional\n\nSecond eye surgery ≤4 weeks after first\n\nToric IOLs or arcuate incisions for residual astigmatism ≤0.50 D\n\nBiometry with ARGOS, IOLMaster 700, or Lenstar\n\nToric alignment with ORA, Callisto, etc.\n\nAssessments:\n\nVisual acuity at 4 m, 66 cm, 40 cm, 33 cm in photopic and mesopic conditions\n\nDefocus curves, contrast sensitivity (with\u002Fwithout glare)\n\nManifest refraction\n\nPatient-reported outcomes via IOLSAT and QUVID questionnaires\n\nMasking: subjects and assessors unaware of IOL assignments\n\nEndpoints (at 3 months):\n\nPrimary: Binocular BCDVA (4 m)\n\nSecondary: DCIVA, DCNVA, UDVA, UIVA, UNVA, defocus curves, refractive outcomes, visual disturbance scores\n\nExploratory: Mesopic VA, low contrast VA, contrast sensitivity, satisfaction scores\n\nEligibility Criteria:\n\nAdults with bilateral age-related cataracts\n\nPlan for bilateral phacoemulsification\n\nExpected postop monocular BCDVA ≤0.1 logMAR (20\u002F25)\n\nResidual astigmatism ≤0.50 D\n\nExclusions include corneal pathology, macular disease, glaucoma, prior ocular surgery, amblyopia, severe dry eye, high HOA (\\>0.6 um), monovision preference, active infection\u002Finflammation, pregnancy\n\nStatistics:\n\nNon-inferiority margin: 0.1 logMAR\n\nSuperiority testing for visual disturbances\n\nStep-down testing hierarchy for primary and secondary outcomes\n\nSample size powered for 80% at α=0.05, accounting for 10% dropout\n\nTwo-proportion Z-tests for dysphotopsia rates\n\nSafety Monitoring:\n\nAdverse Events (AEs) and Serious Adverse Events (SAEs) captured\n\nDefinitions, severity grading, and reporting procedures specified\n\nProtocol deviations documented and reported per IRB requirements\n\nData Handling:\n\nData anonymized via subject numbers\n\nStored securely (locked cabinets, password-protected systems)\n\nStudy registered at ClinicalTrials.gov\n\nVisit Schedule:\n\nScreening: Consent, eligibility, history\n\n1st \\& 2nd Eye Surgery Visits\n\n3-Month Post-Op Visit: Comprehensive visual assessments, questionnaires, AE review","SVI-POPCV-001 Protocol Detailed Description\n\nTitle:\n\nVisual Outcomes in Patients Contralaterally Implanted with PanOptix Pro and Clareon Vivity Compared to Bilateral Implantation of PanOptix Pro\n\nSponsor and Investigator Brian Shafer, MD\n\nShafer Vision Institute, USA\n\nStudy Phase: Investigator-Initiated Trial (IIT)\n\nRTI#: 25-IL73, IIT Proposal #97074289\n\nProtocol Version 1.0 (21 May 2025)\n\nStudy Objective\n\nTo evaluate visual outcomes and patient-reported satisfaction in patients with bilateral age-related cataracts randomized to either:\n\nContralateral implantation (PanOptix Pro in one eye and Clareon Vivity in the other)\n\nBilateral PanOptix Pro implantation\n\nHypotheses:\n\nContralateral approach will be non-inferior in binocular BCDVA at 4 m.\n\nContralateral approach will yield superior outcomes in reducing visual disturbances like halos.\n\nStudy Design Prospective, randomized, double-masked, two-arm, multicenter trial\n\n5 surgeons at 4 sites\n\nN=346 subjects (173 per arm), powered for 80% with 10% dropout buffer\n\nRandomized 1:1\n\nArm 1: PanOptix Pro (dominant eye) + Clareon Vivity (non-dominant eye)\n\nArm 2: Bilateral PanOptix Pro\n\nAll surgeries target emmetropia\n\nSurgical Methods Bilateral phacoemulsification\n\nOptional femtosecond laser-assisted cataract surgery\n\nSecond eye surgery within 4 weeks\n\nResidual astigmatism ≤0.50 D, managed with toric IOLs or arcuate incisions\n\nPreoperative IOL calculation using Barrett Universal II and Barrett Toric Calculator\n\nToric alignment via ORA, Veracity, or digital\u002Ffemtosecond laser marking\n\nBiometry with ARGOS, IOLMaster 700, Lenstar\n\nHOA\u002Fcoma measurement with topography (Cassini, Pentacam, iTrace, Atlas)\n\nAssessment Tools M\\&S Clinical Trial Suite (CTS) for standardized VA testing\n\nValidated questionnaires (IOLSAT, QUVID) for patient-reported outcomes\n\nMeasurements:\n\nPhotopic \\& mesopic VA\n\nDefocus curves\n\nContrast sensitivity with\u002Fwithout glare\n\nManifest refraction\n\nMasking:\n\nSubjects and outcome assessors blinded to IOL assignment\n\nEndpoints\n\nPrimary Endpoint (3 months):\n\nBinocular best-corrected distance VA (BCDVA) at 4 m\n\nSecondary Endpoints (3 months):\n\nBinocular DCIVA at 66 cm\n\nDCNVA at 40 cm and 33 cm\n\nUDVA, UIVA, UNVA at the same distances\n\nDefocus curves over ±3.00 D range\n\nRefractive outcomes (sphere, cyl, MRSE)\n\nVisual disturbance scores via QUVID\n\nExploratory:\n\nMesopic VA\n\nPhotopic low-contrast VA\n\nMesopic contrast sensitivity (with\u002Fwithout glare)\n\nPatient satisfaction via IOLSAT\n\nEligibility\n\nInclusion:\n\nAdults with bilateral age-related cataracts\n\nSuitable for bilateral phacoemulsification\n\nPost-op monocular BCDVA expected ≤0.1 logMAR (20\u002F25)\n\nResidual astigmatism ≤0.50 D\n\nNormal ocular exam except cataract\n\nExclusion:\n\nCorneal pathology or irregular astigmatism\n\nRetinal disease, macular degeneration, glaucoma\n\nSevere dry eye, nystagmus, strabismus\n\nZonular instability or pseudoexfoliation\n\nPrior ocular surgery (including refractive)\n\nMonovision preference\n\nAmblyopia or monofixation\n\nHOA \\>0.6 um\n\nCombined procedures planned\n\nParticipation in conflicting trials\n\nPregnancy\u002Fbreastfeeding\n\nStatistical Analysis Non-inferiority margin: 0.1 logMAR\n\nStep-down analysis order:\n\nBCDVA (non-inferiority)\n\nDCIVA (non-inferiority)\n\nDCNVA 33 cm (superiority)\n\nVisual disturbance rates (superiority) 5-9. Other VA measures (non-inferiority\u002Fsuperiority)\n\nAlpha = 0.05\n\nTwo-proportion Z-test for visual disturbances\n\nt-tests or Wilcoxon tests depending on distribution\n\nDefocus curve comparisons via 2-way ANOVA\n\nSample Size Justification:\n\nPowered for BCDVA difference of 0.05 logMAR with SD 0.15\n\nMinimum \\~250 needed accounting for dropout\n\nCap of \\~70 subjects per surgeon, adjustable with approval\n\nAdverse Event Management AEs: any abnormal ocular signs\u002Fsymptoms\n\nSAEs include death, life-threatening events, hospitalization, disability, congenital anomalies\n\nAdverse Device Effects: linked to IOL or surgical process\n\nSeverity grading: mild, moderate, severe (not same as SAE)\n\nInvestigator assessment of relationship (not\u002Fpossibly\u002Fprobably\u002Fdefinitely related)\n\nImmediate reporting of SAEs\u002FADEs to sponsor\u002FIRB\n\nProtocol deviations documented and reported per IRB policy\n\nData Handling Data de-identified with subject numbers\n\nSource documents secured physically and digitally\n\nStrict confidentiality per law\n\nClinicalTrials.gov registration\n\nIRB oversight for amendments, AE\u002FSAE reports, study closure\n\nConfidentiality and Regulatory Compliance Results may be published without identifying participants\n\nData shared with sponsor, regulatory agencies, IRB\n\nConducted per protocol, GCP, and applicable laws",[18,19],"Cataract","Multifocal Intraocular Lens",[21,22,23,24],"multifocal intraocular lens","cataract","cataract surgery","Presbyopia Correcting IOL","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},346,"ESTIMATED",[33,39],{"type":34,"name":35,"description":36,"armGroupLabels":37},"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",[38],"Contralateral PanOptix Pro and Clareon Vivity",{"type":34,"name":40,"description":41,"armGroupLabels":42},"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.",[43],"Bilateral PanOptix Pro",[45],{"measure":46,"description":47,"timeFrame":48},"Binocular Best-Corrected Distance Visual Acuity (BCDVA) at 4 meters","Binocular BCDVA measured in logMAR under photopic conditions (85 cd\u002Fm²) 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",[],"ALL","18 Years",null,{"inclusion":54,"exclusion":55,"raw_text":56},[],[],"Inclusion Criteria Adult patients (≥18 years old) able and willing to provide informed consent.\n\nBilateral diagnosis of age-related cataracts.\n\nPlanned bilateral cataract removal by phacoemulsification with either:\n\nContralateral implantation of Clareon PanOptix Pro\u002FPanOptix Pro Toric in one eye and Clareon Vivity\u002FVivity Toric in the fellow eye, or\n\nBilateral implantation of Clareon PanOptix Pro\u002FPanOptix Pro Toric.\n\nExpected best monocular corrected distance visual acuity (BCDVA) of 0.1 logMAR (Snellen 20\u002F25) or better in both eyes postoperatively, as determined by the surgeon.\n\nResidual astigmatism expected to be ≤0.50 diopters in both eyes postoperatively (using toric IOLs or arcuate incisions as needed).\n\nNormal ocular findings aside from cataracts.\n\nExclusion Criteria Corneal pathology or irregular astigmatism.\n\nPreexisting macular disease or other retinal degenerative disease expected to cause vision loss.\n\nGlaucoma.\n\nSevere dry eye disease.\n\nNystagmus or strabismus.\n\nZonular laxity or dehiscence, pseudoexfoliation.\n\nAny condition (in the investigator's opinion) that may affect study endpoints.\n\nPrevious history of any ocular surgery, including corneal refractive surgery.\n\nSubjects desiring monovision.\n\nHistory of amblyopia or monofixation syndrome with poor stereoscopic vision.\n\nTotal corneal higher-order aberrations (HOA) greater than 0.6 microns.\n\nAny planned simultaneous or combined procedures at the time of cataract surgery (e.g., MIGS).\n\nParticipation in another clinical study that could interfere with study results.\n\nAny active ocular infection or inflammation.\n\nPregnant, breastfeeding, or planning to become pregnant during the study (as determined by verbal inquiry).",[58,59],"ADULT","OLDER_ADULT",[61,70,78,85,93],{"facility":62,"city":63,"state":64,"zip":65,"country":66,"geoPoint":67},"VIP Eye Care","Baltimore","Maryland","21286","United States",{"lat":68,"lon":69},39.29038,-76.61219,{"facility":71,"city":72,"state":73,"zip":74,"country":66,"geoPoint":75},"Vance Thompson Vision","Alexandria","Minnesota","56308",{"lat":76,"lon":77},45.88524,-95.37754,{"facility":71,"city":79,"state":80,"zip":81,"country":66,"geoPoint":82},"Bozeman","Montana","59718",{"lat":83,"lon":84},45.67965,-111.03856,{"facility":86,"city":87,"state":88,"zip":89,"country":66,"geoPoint":90},"Main Line Surgery Center","Bala-Cynwyd","Pennsylvania","19004",{"lat":91,"lon":92},40.00761,-75.23407,{"facility":94,"city":95,"state":88,"zip":96,"country":66,"geoPoint":97},"Shafer Vision Institute","Plymouth Meeting","19462",{"lat":98,"lon":99},40.10233,-75.27435,[],[102],{"name":103,"affiliation":94,"role":104},"Brian Shafer, MD","PRINCIPAL_INVESTIGATOR",[106,110,113],{"pmid":107,"type":108,"citation":109},"35082481","RESULT","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\u002FOPTH.S347382. eCollection 2022.",{"pmid":111,"type":108,"citation":112},"34050809","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\u002Fs00417-021-05245-6. Epub 2021 May 29.",{"pmid":114,"type":108,"citation":115},"31403494","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\u002FAPO.0000000000000253.",[],{"nct_id":4,"conditions":118,"biomarkers":119},[18],[],{"nct_id":4,"found":14,"summary":52,"prompt_version":52}]