[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556700":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":65,"collaborators":67,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":25,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":25,"enrollmentInfo":80,"targetDuration":25,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":94,"whyStopped":25,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Moorfields Eye Hospital NHS Foundation Trust","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AI-Generated Informative Videos","EXPERIMENTAL","Participants in this arm will receive an AI-generated informative video. The video will provide comprehensive information about cataract surgery, including the procedure, risks, benefits, and postoperative care. The content will be generated using the Synthesia platform, which uses artificial intelligence to create realistic, photo-realistic digital avatars to deliver the information. The aim is to improve patient understanding, satisfaction, and reduce preoperative anxiety compared to traditional information delivery methods. The video will be produced in English for Cohort A, and translated into Bengali for Cohort B.",[13],"Behavioral: AI-Generated Informative Videos",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Written Information Brochures","ACTIVE_COMPARATOR","Participants in this arm will receive the standard information provided to patients undergoing cataract surgery, which consists of written information brochures. These brochures include comprehensive details about the cataract surgery procedure, potential risks, benefits, and postoperative care. The brochures are designed to provide all necessary information to help patients make an informed decision regarding their surgery. The leaflet will be supplied in English for Cohort A, and Bengali for Cohort B.",[19],"Behavioral: Standard Written Information Brochures",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Participants in the experimental arm will receive an AI-generated video designed to provide comprehensive information about cataract surgery. The video will cover key aspects of the procedure, including the nature of the surgery, potential risks, benefits, and postoperative care. The video will be produced in English for Cohort A, and translated into Bengali for Cohort B.\n\nThe video will be delivered to participants via a secure link sent to their mobile devices or email. Patients can watch the video at their convenience, and they are encouraged to view it as many times as necessary to fully understand the information provided. The video link will be provided once after the initial clinic appointment, but patients can access and watch the video multiple times.\n\nThe videos will be created using the Synthesia platform, which uses artificial intelligence to generate realistic, photo-realistic digital avatars that deliver the information in a personalized and engaging manner.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Participants in the control arm will receive traditional written information brochures about cataract surgery. These brochures are designed to deliver detailed and essential information in a clear and understandable format. The brochures will be handed to participants during their face-to-face clinic appointment. Patients can read the material at their convenience and keep it for future reference. These brochures follow standardized guidelines and recommendations to ensure that all relevant information is included and presented in an accessible manner. The leaflet will be supplied in English for Cohort A, and Bengali for Cohort B.",[15],[30],{"name":31,"affiliation":5,"role":32},"Swan Kang, MBBS, MBioch (Oxon), FRCOphth","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},"CONTACT","07958585904","swan.kang1@nhs.net",[39,56],{"facility":40,"status":25,"city":41,"state":25,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Moorfields Eye Hospital Stratford","London","E15 4BQ","United Kingdom","UK",{"type":46,"coordinates":47},"Point",[48,49],-0.12574,51.50853,{"lat":49,"lon":48},[52,53],{"name":31,"role":35,"phone":25,"phoneExt":25,"email":25},{"name":54,"role":55,"phone":25,"phoneExt":25,"email":25},"Sara Memon, MBBS, BSc","SUB_INVESTIGATOR",{"facility":57,"status":25,"city":41,"state":25,"zip":58,"country":43,"countryCode":44,"cosmosGeoPoint":59,"geoPoint":61,"contacts":62},"Moorfields Eye Hospital","EC1V 2PD",{"type":46,"coordinates":60},[48,49],{"lat":49,"lon":48},[63,64],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},{"name":54,"role":55,"phone":25,"phoneExt":25,"email":25},{"type":66,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[68],{"name":69,"class":70},"Medical Protection Society Foundation","UNKNOWN","100556700","ai-enhanced-consent-for-cataract-surgery-100556700",false,"NCT06528509","AI-Enhanced Consent for Cataract Surgery","An Artificial-intelligence-powered Intervention to Aid the Informed Consent Process for Cataract Surgery for English Speaking and Bengali Speaking Patient Population Groups: A Mixed-methods Randomised Control Trial","Inclusion Criteria:\n\n* Have capacity to consent\n* Listed for first time cataract surgery\n* English speakers for Cohort A\n* Bengali speakers for Cohort B\n\nExclusion Criteria:\n\n* Previously undergone cataract surgery\n* Partner who has undergone cataract surgery\n* Below the age of 18\n* Unable to utilise a device for watching information videos and completing quiz","ALL","18 Years",{"count":81,"type":82},200,"ESTIMATED","INTERVENTIONAL",[85],"NA","This research focuses on enhancing the informed process for patients before undergoing cataract surgery. Currently, this process involves verbal discussions and written materials that may not fully address patients' understanding of the surgery, its risks, and benefits. This study aims to introduce an innovative approach using artificial intelligence (AI) to generate informative videos tailored to patients' needs, accounting for education level, ethnicity, and language barriers.\n\nWhy is this important? Informed consent is not just a legal requirement; but it's a fundamental patient right. Ensuring patients truly understand their treatment options leads to better satisfaction, both from the patient and clinician's perspective.\n\nThis study compares the effectiveness of AI-generated videos against traditional information delivery methods (information brochures). Patients scheduled for cataract surgery will experience either the new AI video approach or the standard process. The goal is to see if the videos lead to better understanding of the procedure and overall satisfaction. The investigators will be running the study in two parallel cohorts - with Cohort A involving an English speaking population, and Cohort B a Bengali speaking population with all patient facing materials translated into Bengali.\n\nThis research is crucial for patients seeking clarity about cataract surgery, for doctors aiming to improve patient care, and for researchers exploring patient education innovations. Funded by the Medical Protection Society (MPS), the investigators hope this intervention has broader effects such as reducing the number of complaints and litigations, improving the efficiency of consenting for surgery and delivering information, and improving theatre utilisation by reducing last minute cancellations.",[88],"Cataract",[90,91,92,93],"Cataract surgery","Complaints","Litigation","Informed consent","NOT_YET_RECRUITING","2024-07-25",{"date":97,"type":98},"2024-07-30","ACTUAL",{"date":100,"type":82},"2024-09-11",{"date":102,"type":82},"2026-09-11",{"name":5,"class":6},2]