[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07502456":3,"trial-entities:NCT07502456":126,"trial-summary:NCT07502456":129},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":50,"secondary_outcomes":55,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":15,"eligibility_criteria":59,"std_ages":68,"locations":71,"central_contacts":113,"overall_officials":119,"references":124,"see_also_links":125},"NCT07502456","ILM335-P001","Clareon TruPlus Study","Clareon TruPlus Single-Arm Study","RECRUITING","2028-06","2026-06","2026-06-03","2026-05-26","Alcon Research","INDUSTRY",false,"The purpose of this research study is to generate safety and performance data for Clareon TruPlus Monofocal Intraocular Lenses (IOLs). IOLs are medical devices that are implanted in the eye during cataract surgery to restore clear vision after the cloudy natural lens has been removed. IOLs are intended to remain in the eyes for the duration of the patient's lifetime.","In this study, subjects will be implanted with Clareon TruPlus Monofocal IOLs. The IOL to be implanted (Non-Toric or Toric) will be based on the recommendation of an IOL calculator.\n\nSubjects will attend 8 study visits, including one preoperative visit, two surgical visits, and five postoperative visits. The second eye surgery will occur 0-14 days after the first eye surgery. The total duration of a subject's participation in the study will be approximately 13 months.",[19,20],"Aphakia","Astigmatism",[22],"Cataract","INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},122,"ESTIMATED",[31,39,45],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":37},"DEVICE","Clareon TruPlus Monofocal Non-Toric IOL","Monofocal IOL implanted in the capsular bag in the eye for the visual correction of aphakia in adult patients. The Clareon TruPlus IOL is designed to maintain distance image quality while slightly extending the depth of focus compared to standard monofocal IOLs.",[36],"Clareon TruPlus Monofocal IOL",[38],"Models REYWT0, REYAT0, RECWT0, RECAT0",{"type":32,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Clareon TruPlus Monofocal Toric IOL","Monofocal IOL implanted in the capsular bag in the eye for the visual correction of aphakia and pre-existing corneal astigmatism. The Clareon TruPlus IOL is designed to maintain distance image quality while slightly extending the depth of focus compared to standard monofocal IOLs.",[36],[44],"Models REYWT3, REYWT4, REYWT5, REYAT3, REYAT4, REYAT5, RECWT3, RECWT4, RECWT5, RECAT3, RECAT4, RECAT5.",{"type":46,"name":47,"description":48,"armGroupLabels":49},"PROCEDURE","Phacoemulsification","Minimally invasive surgery technique that utilizes ultrasonic vibrations to break up (emulsify) and remove a cloudy lens through a small, self-sealing, 2-3mm incision",[36],[51],{"measure":52,"description":53,"timeFrame":54},"Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA)","Visual acuity (VA) will be assessed binocularly (both eyes together) with correction in place under photopic (well-lit) conditions at a distance of 4 meters. BCDVA will be measured using letter charts and recorded in logarithm of the Minimum Angle of Resolution (logMAR). The LogMAR VA scale ranges from -0.30 (20\u002F10 Snellen) to 1.00 (20\u002F200 Snellen). A LogMAR value of 0 equates to 20\u002F20 Snellen VA (normal distance eyesight), with negative LogMAR values representing better than 20\u002F20 VA. Subjects with at least one implanted eye with a toric IOL will be categorized as toric as specified in the statistical analysis plan. No hypothesis testing is pre-specified for this endpoint","Day 0 preoperative, Month 1, Month 3, Month 12",[],"ALL","22 Years",null,{"inclusion":60,"exclusion":64,"raw_text":67},[61,62,63],"Diagnosed with bilateral cataracts and planned bilateral cataract extraction by routine phacoemulsification.","Potential postoperative BCDVA of 0.2 logMAR or better in each eye in the expert medical opinion of the investigator.","Astigmatism suitable for correction with available toric IOL models.",[65,66],"Age-related macular degeneration (AMD), glaucoma, diabetic retinopathy, and other eye conditions as specified in the protocol.","Moderate to severe dry eye that would affect study measurements.","Key Inclusion Criteria:\n\n* Diagnosed with bilateral cataracts and planned bilateral cataract extraction by routine phacoemulsification.\n* Potential postoperative BCDVA of 0.2 logMAR or better in each eye in the expert medical opinion of the investigator.\n* Astigmatism suitable for correction with available toric IOL models.\n* Other protocol-specified inclusion criteria may apply.\n\nKey Exclusion Criteria:\n\n* Age-related macular degeneration (AMD), glaucoma, diabetic retinopathy, and other eye conditions as specified in the protocol.\n* Moderate to severe dry eye that would affect study measurements.\n* Other protocol-specified exclusion criteria may apply.",[69,70],"ADULT","OLDER_ADULT",[72,81,89,97,105],{"facility":73,"status":8,"city":74,"state":75,"zip":76,"country":77,"geoPoint":78},"Eye Doctors of Arizona","Phoenix","Arizona","85028","United States",{"lat":79,"lon":80},33.44838,-112.07404,{"facility":82,"status":8,"city":83,"state":84,"zip":85,"country":77,"geoPoint":86},"Cleveland Eye Clinic","Brecksville","Ohio","44141",{"lat":87,"lon":88},41.31978,-81.62679,{"facility":90,"status":8,"city":91,"state":92,"zip":93,"country":77,"geoPoint":94},"Carolina Eyecare Physicians LLC","Mt. Pleasant","South Carolina","29464",{"lat":95,"lon":96},32.79407,-79.86259,{"facility":98,"status":8,"city":99,"state":100,"zip":101,"country":77,"geoPoint":102},"Berkeley Eye Center","Sugar Land","Texas","77478",{"lat":103,"lon":104},29.61968,-95.63495,{"facility":106,"status":8,"city":107,"state":108,"zip":109,"country":77,"geoPoint":110},"The Eye Institute of Utah","Salt Lake City","Utah","84107",{"lat":111,"lon":112},40.76078,-111.89105,[114],{"name":115,"role":116,"phone":117,"email":118},"Alcon Call Center","CONTACT","1-888-451-3937","alcon.medinfo@alcon.com",[120],{"name":121,"affiliation":122,"role":123},"Clinical Trial Lead, Surgical","Alcon Research, LLC","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":127,"biomarkers":128},[19,20,22],[],{"nct_id":4,"found":130,"summary":131,"prompt_version":141},true,{"design":132,"status":133,"heading":134,"summary":135,"follow_up":136,"word_count":137,"commitments":138,"compensation":139,"drugs_mentioned":140},"This study is testing two types of Clareon TruPlus Monofocal IOLs in about 122 adult participants. The type of IOL you receive will be based on your doctor's recommendation.","completed","Clareon TruPlus Study for Aphakia and Astigmatism","This study is testing the safety and performance of new lenses called Clareon TruPlus Monofocal Intraocular Lenses (IOLs). These IOLs are implanted in your eye during cataract surgery to help you see clearly after a cloudy natural lens is removed. Some lenses are designed for people with astigmatism (a common vision problem caused by an imperfectly curved eye surface). The study aims to see how well these lenses help improve your distance vision. You might be able to join if you have cataracts in both eyes and are planning to have cataract surgery. The study is looking for 122 participants.","Your vision will be checked at 1 month, 3 months, and 12 months after surgery.",100,"You will have 8 study visits over approximately 13 months, including one visit before surgery, two surgery visits, and five visits after surgery. Your second eye surgery will happen 0-14 days after the first.","Not stated in the trial record.",[],"v2"]