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PanOptix",{"label":15,"type":16,"description":11,"interventionNames":17},"Bilateral Clareon PanOptix Pro IOL implantation","EXPERIMENTAL",[18],"Drug: Clareon PanOptix PRO",{"label":20,"type":16,"description":11,"interventionNames":21},"Clareon PanOptix Pro in the non-dominant eye and Clareon Vivity in the dominant eye",[22],"Drug: Mix-and-Match PanOptix\u002FVivity",[24,28,33],{"type":25,"name":26,"description":9,"armGroupLabels":27,"otherNames":11},"DEVICE","Clareon PanOptix",[9],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":11},"DRUG","Clareon PanOptix PRO","Bilateral Clareon PanOptix PRO IOL implantation",[15],{"type":29,"name":34,"description":20,"armGroupLabels":35,"otherNames":11},"Mix-and-Match PanOptix\u002FVivity",[20],[37],{"name":38,"affiliation":5,"role":39},"Morgan Micheletti, MD","PRINCIPAL_INVESTIGATOR",[41],{"name":42,"role":43,"phone":44,"phoneExt":11,"email":45},"Tetiana Huff","CONTACT","713-620-7640","tetiana.huff@berkeleyeye.com",[47,67],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Shafer Vision Institute","RECRUITING","Plymouth Meeting","Pennsylvania","19462","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-75.27435,40.10233,{"lat":59,"lon":58},[62,65],{"name":63,"role":43,"phone":11,"phoneExt":11,"email":64},"Ailinn Dunn","ailinn@shafervision.com",{"name":66,"role":39,"phone":11,"phoneExt":11,"email":11},"Brian Shafer",{"facility":5,"status":49,"city":68,"state":69,"zip":70,"country":53,"countryCode":54,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Houston","Texas","77027",{"type":56,"coordinates":72},[73,74],-95.36327,29.76328,{"lat":74,"lon":73},[77,78],{"name":42,"role":43,"phone":44,"phoneExt":11,"email":45},{"name":38,"role":39,"phone":11,"phoneExt":11,"email":11},{"type":80,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[82],{"name":83,"class":84},"Sengi","INDUSTRY","100586953","phase-4-a-prospective-randomized-subject-and-vision-assessor-masked-multicenter-study-comparing-bilateral-clareon-panoptix-bilateral-clareon-panoptix-pro-and-mixed-clareon-panoptix-provivity-intraocular-lens-implantation-in-cataract-subjects-100586953",false,"NCT06922084","A Prospective, Randomized, Subject and Vision-assessor Masked, Multicenter Study Comparing Bilateral Clareon PanOptix, Bilateral Clareon PanOptix Pro, and Mixed Clareon PanOptix Pro\u002FVivity Intraocular Lens Implantation in Cataract Subjects","Inclusion Criteria:\n\n* Adult cataract patients aged 40 years and older scheduled for age related cataract surgery in both eyes.\n* Ability to understand and sign an ethics committee-approved informed consent form.\n* Willingness and ability to attend all scheduled study visits as required by the protocol.\n* Postoperative potential visual acuity of 20\u002F25 or better in each eye, as determined by the investigator.\n* Preoperative corneal astigmatism that can be corrected with a T3 or T4 toric IOL, or with a spherical IOL and LRIs or AKs resulting in a predicted postoperative astigmatism of less than 0.5 diopters (D).\n* Ability to understand and complete questionnaires.\n\nExclusion Criteria:\n\n* Women who are pregnant, planning to become pregnant during the study, or breastfeeding.\n* Ocular conditions that could confound study results, including moderate to severe corneal pathology, irregular astigmatism, moderate to severe dry eye, preexisting retinal diseases such as macular degeneration or diabetic retinopathy.\n* Any form of confirmed glaucomatous damage (ie, mild, moderate, or severe glaucoma).\n* Participation in another clinical study that could interfere with the results.\n* Systemic conditions that may affect healing or visual outcomes (e.g., uncontrolled diabetes mellitus, certain autoimmune disorders).\n* Subjects with nystagmus, strabismus, zonular laxity or dehiscence, and pseudoexfoliation.\n* Prior ocular surgery (except for uncomplicated cataract surgery in the fellow eye).\n* Participants desiring monovision.\n* Any active ocular infection or inflammation (except for routine post-operative inflammation in the fellow eye)\n* Psychiatric or cognitive disorders that may impair the ability to comply with study procedures or provide accurate self-assessments.\n* RMS total higher-order aberrations (HOAs) \\>0.70 µm or coma \\>0.40 µm as measured by tomography or topography with a 4 mm pupil setting.",true,"ALL","40 Years",{"count":95,"type":96},320,"ESTIMATED","INTERVENTIONAL",[99],"PHASE4","Prospective, randomized, multicenter, multi-arm, subject and vision-assessor-masked, two stage study with Stage 1 as a three-arm initial enrollment period, followed by Stage 2 as a head-to-head study refined based on the Stage 1 data.",[102],"Cataract","2025-04-03",{"date":105,"type":106},"2025-04-10","ACTUAL",{"date":108,"type":106},"2025-03-17",{"date":110,"type":96},"2026-04",{"name":5,"class":6},2]