[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604259":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":21,"studyPopulation":13,"armGroups":22,"interventions":35,"overallOfficials":48,"centralContacts":53,"locations":59,"responsibleParty":103,"collaborators":13,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":13,"eligibilityCriteria":110,"healthyVolunteers":107,"sex":111,"minAge":112,"maxAge":13,"enrollmentInfo":113,"targetDuration":13,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":62,"whyStopped":13,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Alcon Research","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Cumulative ocular adverse events (AEs), including Secondary Surgical Interventions (SSIs)","The number of adverse events, including SSI's, will be calculated. An SSI is a subsequent operation performed to address issues or complications arising from a previous surgical procedure. AEs will be collected starting at Day 0 after informed consent. SSIs will be collected starting Day 1.","From Day 0 up to Month 12",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":18,"observationalModel":13,"timePerspective":13,"maskingInfo":19},"NON_RANDOMIZED","PARALLEL","Contralateral implantation","DEVICE_FEASIBILITY",{"masking":20,"maskingDescription":13,"whoMasked":13},"NONE","This study will enroll adult subjects who require cataract surgery in both eyes. One eye will receive the AAL-FAIOL and the other eye will receive the BAL-FAIOL. The two eye surgeries will be separated by 14-35 days. Subjects will attend follow up visits for approximately 1 year. If needed, the AAL lens may be adjusted after surgery with a laser to help give the participant better vision.",[23,30],{"label":24,"type":25,"description":26,"interventionNames":27},"AAL-FAIOL","EXPERIMENTAL","The clouded lens will be removed by phacoemulsification, after which the AAL-FAIOL will be implanted in one eye.",[28,29],"Device: AAL-FAIOL","Procedure: Phacoemulsification",{"label":31,"type":25,"description":32,"interventionNames":33},"BAL-FAIOL","The clouded lens will be removed by phacoemulsification, after which the BAL-FAIOL will be implanted in one eye.",[34,29],"Device: BAL-FAIOL",[36,40,43],{"type":37,"name":24,"description":38,"armGroupLabels":39,"otherNames":13},"DEVICE","Intraocular lens (IOL) placed into the lens capsule of the eye during cataract surgery. IOLs are implantable medical devices intended for long-term use over the lifetime of the pseudophakic subject. Laser energy to specified locations can be used to allow a change in power for far distances.",[24],{"type":37,"name":31,"description":41,"armGroupLabels":42,"otherNames":13},"Intraocular lens (IOL) placed into the lens capsule of the eye during cataract surgery. IOLs are implantable medical devices intended for long-term use over the lifetime of the pseudophakic subject.",[31],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":13},"PROCEDURE","Phacoemulsification","Cataract surgery technique that uses ultrasound to break up and remove the clouded lens, allowing for intraocular lens (IOL) implantation.",[24,31],[49],{"name":50,"affiliation":51,"role":52},"Clinical Trial Lead, Surgical","Alcon Research, LLC","STUDY_DIRECTOR",[54],{"name":55,"role":56,"phone":57,"phoneExt":13,"email":58},"Alcon Call Center","CONTACT","1-888-451-3937","alcon.medinfo@alcon.com",[60,72,83,93],{"facility":61,"status":62,"city":63,"state":13,"zip":13,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":13},"Clinica 20\u002F20","RECRUITING","San José","Costa Rica","CR",{"type":67,"coordinates":68},"Point",[69,70],-84.08489,9.93388,{"lat":70,"lon":69},{"facility":73,"status":74,"city":75,"state":13,"zip":13,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":82,"contacts":13},"Instituto Espaillat Cabral","NOT_YET_RECRUITING","Santo Domingo","Dominican Republic","DO",{"type":67,"coordinates":79},[80,81],-69.89232,18.47186,{"lat":81,"lon":80},{"facility":84,"status":74,"city":85,"state":13,"zip":13,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":92,"contacts":13},"Centro Panamericano de Ojos \u002F Clinica Lopez Beltran","San Salvador","El Salvador","SV",{"type":67,"coordinates":89},[90,91],-89.18718,13.68935,{"lat":91,"lon":90},{"facility":94,"status":62,"city":95,"state":13,"zip":13,"country":96,"countryCode":97,"cosmosGeoPoint":98,"geoPoint":102,"contacts":13},"Panama Eye Center","Panama City","Panama","PA",{"type":67,"coordinates":99},[100,101],-79.51973,8.9936,{"lat":101,"lon":100},{"type":104,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100604259","feasibility-study-of-an-accommodating-iol-design-100604259",false,"NCT07147192","Feasibility Study of an Accommodating IOL Design","Key Inclusion Criteria:\n\n* Able to understand and sign an Informed Consent Form.\n* Willing and able to attend all scheduled study visits required per protocol.\n* Diagnosed with bilateral cataracts requiring removal by phacoemulsification.\n* Preoperative corneal astigmatism equal to or less than 1.50 diopter (D) in both eyes.\n* Other protocol-defined inclusion criteria may apply.\n\nKey Exclusion Criteria:\n\n* Women of childbearing potential who are pregnant, intend to become pregnant during the study, or are breastfeeding.\n* Taking medications that could increase risk or may affect accommodation.\n* Eye conditions as specified in the protocol, including glaucoma or ocular hypertension.\n* Medical conditions that could increase operative risk as specified in the protocol.\n* Other protocol-defined exclusion criteria may apply.","ALL","22 Years",{"count":114,"type":115},85,"ESTIMATED","INTERVENTIONAL",[118],"NA","The purpose of this clinical study is to assess safety and explore usability and effectiveness of the test product, AAL-FAIOL. This study will be conducted in Central America.",[121],"Aphakia",[123],"Cataract","2026-05-18",{"date":126,"type":127},"2026-05-19","ACTUAL",{"date":129,"type":127},"2025-12-03",{"date":131,"type":115},"2028-01",{"name":5,"class":6},4]