[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03022773":3,"trial-entities:NCT03022773":76,"trial-summary:NCT03022773":82},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":33,"secondary_outcomes":40,"sex":43,"minimum_age":44,"maximum_age":45,"healthy_volunteers":46,"eligibility_criteria":47,"std_ages":54,"locations":58,"central_contacts":68,"overall_officials":69,"references":74,"see_also_links":75},"NCT03022773","IRB # 80132","Macular Pigment Measurements in Eye & Other Tissues","ENROLLING_BY_INVITATION","2030-06","2026-04","2026-05-04","2015-06","University of Utah","OTHER",false,"The purpose of this study is to understand the role of nutrition and its effects on the eye and other tissues. The investigators propose to study this by validating and correlating various non-invasive measurement methods of carotenoid concentrations in the human eye and skin tissue.\n\nA secondary objective is to correlate blood levels of carotenoids on a sub-set of participants.","The macula of the human retina (the structure responsible for high acuity vision essential for reading, driving and recognizing faces) is colored an intense yellow due to the deposition of two carotenoid compounds, lutein and zeaxanthin. These xanthophyll carotenoids are derived exclusively from the diet, and are hypothesized to protect the macula from light-induced oxidative damage by virtue of their light-screening and antioxidant properties.\n\nEpidemiological studies have shown that high dietary intake and blood levels of lutein and zeaxanthin are associated with lower rates of vision loss due to age-related macular degeneration (AMD).\n\nIt is of interest to correlate carotenoid levels in the eye and skin tissues with blood levels of carotenoid compounds.",[18,19],"Macular Pigmentation","Skin Pigment",[],"INTERVENTIONAL","BASIC_SCIENCE",[24],"NA",{"count":26,"type":27},10000,"ESTIMATED",[29],{"type":13,"name":30,"description":31,"armGroupLabels":32},"Carotenoid measurements","Carotenoid measurements of the eye (macula) are obtained through non-invasive ophthalmic photographs using the Heidelberg Spectralis imaging system.\n\nCarotenoid measurements of the skin are measured by a laboratory instrument that uses a painless blue laser light for exposure of the skin and a photodetector for scattered light.\n\nCarotenoid measurements in the blood are obtained through routine venipuncture.",[30],[34,38],{"measure":35,"description":36,"timeFrame":37},"Carotenoid levels in the eye","all study procedures are generally completed in a single study visit","at enrollment",{"measure":39,"description":36,"timeFrame":37},"Carotenoid levels in the skin",[41],{"measure":42,"description":36,"timeFrame":37},"Carotenoid levels in the blood","ALL","7 Years",null,true,{"inclusion":48,"exclusion":51,"raw_text":53},[49,50],"Any patient age 7 or older, undergoing routine dilated ophthalmology examinations at the Moran Eye Center will be eligible to participate.","Patients with adult vitelliform dystrophy. (This condition initially presents in adulthood as bilateral subtle and often asymptomatic macular lesions, which are often misdiagnosed as early age-related macular degeneration (AMD)).",[52],"Patients under age 7 will not be eligible to participate.","Inclusion Criteria:\n\n* Any patient age 7 or older, undergoing routine dilated ophthalmology examinations at the Moran Eye Center will be eligible to participate.\n* Patients with adult vitelliform dystrophy. (This condition initially presents in adulthood as bilateral subtle and often asymptomatic macular lesions, which are often misdiagnosed as early age-related macular degeneration (AMD)).\n\nExclusion Criteria:\n\n* Patients under age 7 will not be eligible to participate.",[55,56,57],"CHILD","ADULT","OLDER_ADULT",[59],{"facility":60,"city":61,"state":62,"zip":63,"country":64,"geoPoint":65},"University of Utah John A. Moran Eye Center","Salt Lake City","Utah","84132","United States",{"lat":66,"lon":67},40.76078,-111.89105,[],[70],{"name":71,"affiliation":72,"role":73},"Paul Bernstein, MD, PhD","University of Utah Moran Eye Center","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":77,"biomarkers":81},[78,79,80],"Adult vitelliform macular dystrophy","Macular pigmentation","Skin pigmentation",[],{"nct_id":4,"found":14,"summary":45,"prompt_version":45}]