[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100474470":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":35,"locations":44,"responsibleParty":65,"collaborators":68,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":18,"enrollmentInfo":91,"targetDuration":18,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":47,"whyStopped":18,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Queen's University, Belfast","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Free near and distance glasses","EXPERIMENTAL","All participants randomised to the intervention group will be provided with free near and\u002For distance spectacles based on the results of refraction. Glasses will be provided at the time of enrolment into the study. The participants will be asked to choose from an assortment of 20 frames. Participants will be asked to report to the study team member in case of any issue with spectacles or if spectacles are lost or broken. Replacement glasses will be provided in case of broken or lost spectacles whenever required. Participants will undergo annual eye exams and refraction, and change of glasses will be prescribed as needed.",[13],"Device: Free near and Distance Vision glasses",{"label":15,"type":16,"description":17,"interventionNames":18},"Control-No treatment","NO_INTERVENTION","All participants randomised to the control group will receive a prescription for spectacles and given free near and\u002For distance glasses as needed at study close out.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Free near and Distance Vision glasses","Intervention Description: All participants randomised to the intervention group will be provided with free near and\u002For distance spectacles based on the results of refraction.Glasses will be provided at the time of enrolment in the study.",[9],[26,29,32],{"name":27,"affiliation":5,"role":28},"Nathan G Congdon, MD, MPH","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":31,"role":28},"Rohit C Khanna, MPH","L.V. Prasad Eye Institute",{"name":33,"affiliation":34,"role":28},"Suvarna Alladi, DM","National Institute of Mental Health and Neuro Sciences, India",[36,41],{"name":27,"role":37,"phone":38,"phoneExt":39,"email":40},"CONTACT","+44(0)289097","8929","n.congdon@qub.ac.uk",{"name":30,"role":37,"phone":42,"phoneExt":18,"email":43},"914035225600","rohit@lvpei.org",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"L V Prasad Eye Institute","RECRUITING","Hyderabad","Telangana","500086","India","IN",{"type":54,"coordinates":55},"Point",[56,57],78.45636,17.38405,{"lat":57,"lon":56},[60,61],{"name":30,"role":37,"phone":42,"phoneExt":18,"email":43},{"name":62,"role":37,"phone":63,"phoneExt":18,"email":64},"Srinivas Marmamula, PhD","914035225613","sri.marmamula@lvpei.org",{"type":28,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Nathan Congdon","Professor",[69,70,71,73,75,77,79],{"name":31,"class":6},{"name":34,"class":6},{"name":72,"class":6},"The George Institute",{"name":74,"class":6},"Johns Hopkins University",{"name":76,"class":6},"University of Michigan",{"name":78,"class":6},"Clearly",{"name":80,"class":6},"Belfast Health and Social Care Trust","100474470","cognitive-level-enhancement-through-vision-exams-and-refraction-100474470",false,"NCT05458323","Cognitive Level Enhancement Through Vision Exams and Refraction","Cognitive Level Enhancement Through Vision Exams and Refraction: a Randomized Controlled Trial to Assess Impact of Near and Distance Spectacles on Reducing Rates of Cognitive Decline With Aging in Community Dwelling Older People in India","CLEVER","Inclusion Criteria\n\n1. Community dwelling\n2. Residency\n\n   a. Participants must plan to reside in the local area for the study duration\n3. Presenting vision in the better eye due to uncorrected refractive error\n\n   1. Impaired distance vision less than 6\u002F18\n   2. Near vision less than N6 at 40 cm\n4. Willingness\n\n   1. to participate\n   2. to be randomized\n   3. to adhere to the protocol\n\nExclusion criteria\n\n1. Impaired baseline cognition\n\n   a. HMSE score less than or equal to 18\n2. Non-refractive causes of vision impairment\n3. Severely impaired mobility\n\n   1. immobile\n   2. bedridden\n   3. wheelchair\n   4. using walker\n4. Severe medical illness likely to limit the life span\n\n   1. Cancer\n   2. Heart disease\n   3. Stroke\n   4. HIV or AIDS\n   5. Chronic lung disease\n   6. Kidney disease\n5. Hearing loss assessment\n\n   1. self-reported hearing impairment\n   2. inability to hear\n   3. fail in whisper test hearing screening(unable to repeat three out of six words)","ALL","60 Years",{"count":92,"type":93},820,"ESTIMATED","INTERVENTIONAL",[96],"NA","The investigators aim to conduct a mixed-method study in which a randomised controlled trial (RCT) and a descriptive qualitative study will be conducted. The RCT aims to determine whether free near and distance glasses provided to residents in Hyderabad, India, aged ≥ 60 years, with under- or un- corrected refractive error and normal baseline hearing and cognition (HMSE \\> 18), can improve quality of life, reduce falls, reduce depression, improve social interaction and physical activity cost-effectively over 36 months. The primary qualitative research aim is to a) contextualize the RCT with information on the milieu and culture in which the trial will be conducted; b) provide data on the lived experiences of older adults with reduced vision in the study area, and c) conduct a process evaluation of the trial.\n\nThe primary outcome measure is the three-year change in cognition measured by LASI- DAD (Longitudinal Aging Study in India(LASI)- Diagnostic Assessment of Dementia(DAD) global cognitive score.\n\nSecondary Outcome Measures: Three year change in Quality of Life score measured by WHO QOL-BREF; Visual functioning from the RASCH-scaled version of INDVFQ(Indian Visual Functioning(INDVFQ);self-reported physical activity score measured using IPAQ questionnaire; PHQ9 score; domain specific cognitive score (orientation, executive function, language\u002Ffluency, memory) measured by HMSE; Total cost of care including direct and indirect costs; Quality adjusted life years; Incremental Cost Effectiveness Ratio; Number of falls measured by Quick Screen score over the three years; Social network density at 3 years (SNI 1-3 represents a \"limited\" social network, 4-5 is a \"medium\" social network, and SNI ≥6 is a \"diverse\" social network) measured by the SNI score; An additional secondary outcome will be LASI-DAD global cognitive score analysed by excluding any tests determined pre-hoc to depend on visual acuity.",[99],"Refractive Errors",[101,102,103,104,105,106],"Cognitive Decline","Elderly","Refractive Error","Spectacles","cost effectiveness analysis","dementia","2026-03-04",{"date":109,"type":110},"2026-03-06","ACTUAL",{"date":112,"type":110},"2024-01-18",{"date":114,"type":93},"2028-12-31",{"name":5,"class":6},1]