[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06650358":3,"trial-entities:NCT06650358":67,"trial-summary:NCT06650358":72},{"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":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":27,"interventions":30,"primary_outcomes":35,"secondary_outcomes":40,"sex":41,"minimum_age":25,"maximum_age":25,"healthy_volunteers":15,"eligibility_criteria":42,"std_ages":49,"locations":53,"central_contacts":63,"overall_officials":64,"references":65,"see_also_links":66},"NCT06650358","IIT-004-02","Clinical Outcomes of Patients with LAL+ in At Least One Eye","CLINICAL OUTCOMES of BILATERAL PSEUDOPHAKIC PATIENTS with a LIGHT ADJUSTABLE LENS+ (LAL)+ IMPLANTED in AT LEAST ONE EYE","ENROLLING_BY_INVITATION","2025-02-01","2024-10","2024-10-21","2024-10-16","Frank A. Bucci, Jr., M.D.","OTHER",false,"The objective of this study is to collect data on bilateral pseudophakic patients implanted with the RxSight Light Adjustable Lens+ (LAL+) in at least one eye","A retrospective-prospective, single-center study will be conducted. Patient charts will be retrospectively reviewed to collect data from the patient's comprehensive preoperative exam. Subjects will attend one stud visit post final LDD light treatment.",[19],"IOL, Cataract",[21,22,23],"LAL+","Light Adjustable Lens+","Mix and match IOLs","OBSERVATIONAL",null,[],{"count":28,"type":29},25,"ESTIMATED",[31],{"type":32,"name":22,"description":33,"armGroupLabels":34},"DEVICE","The Light Adjustable Lens+ (LAL+) is a posterior chamber, UV absorbing, three-piece, foldable, photo reactive silicone intraocular lens with a squared-posterior optic edge intended to be implanted in the capsular bag following phacoemulsification. Selective exposure to the implanted LAL+ using the Light Delivery Device (LDD) to deliver a spatially profiled UV light produces modifications in the lens curvature resulting in a spherical or spherocylindrical power change postoperatively. A subsequent lock-in exposure is delivered to the implanted LAL+ to stabilize the lens power. The LAL+ has a modified aspheric anterior surface that creates a small continuous increase in central lens power, which is designed to slightly extend the depth of focus.",[21],[36],{"measure":37,"description":38,"timeFrame":39},"Patient Satisfaction","Description: Subjective questionnaire explores the frequency\u002Fneed for glasses for various visual functions at distance\u002Fintermediate\u002Fnear, experience with dysphotopsias, and overall satisfaction of visual function without glasses.","3-18 months after phacoemulsification",[],"ALL",{"inclusion":43,"exclusion":46,"raw_text":48},[44,45],"Adults with bilateral pseudophakia who have been implanted with the LAL+ in at least one eye and who have completed LDD light treatments","Sign a written Informed Consent Form",[47],"Visually significant eye disease","Inclusion Criteria:\n\n* Adults with bilateral pseudophakia who have been implanted with the LAL+ in at least one eye and who have completed LDD light treatments\n* Sign a written Informed Consent Form\n\nExclusion Criteria:\n\n* Visually significant eye disease",[50,51,52],"CHILD","ADULT","OLDER_ADULT",[54],{"facility":55,"city":56,"state":57,"zip":58,"country":59,"geoPoint":60},"Bucci Laser Vision Institute","Wilkes-Barre","Pennsylvania","18702","United States",{"lat":61,"lon":62},41.24591,-75.88131,[],[],[],[],{"nct_id":4,"conditions":68,"biomarkers":71},[69,70],"Cataract","Pseudophakia",[],{"nct_id":4,"found":15,"summary":25,"prompt_version":25}]