[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03475173":3,"trial-entities:NCT03475173":89,"trial-summary:NCT03475173":99},{"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":24,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":41,"secondary_outcomes":46,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":50,"eligibility_criteria":51,"std_ages":55,"locations":58,"central_contacts":75,"overall_officials":83,"references":87,"see_also_links":88},"NCT03475173","201611825","New Non-invasive Modalities for Assessing Retinal Structure and Function","New Non-invasive Modalities for Assessing Retinal Structure and Function:Preliminary Investigation","RECRUITING","2028-03-01","2025-05","2025-11-24","2019-05-06","Randy Kardon","OTHER",false,"This study investigates a new technology to assess the structure and function inside the eye. Retinal imaging of subjects with inner and outer retinal defects to detect areas of abnormal structure and function compared to other visual function tests.",null,[19,20,21,22,23],"Ischemic Optic Neuropathy","Branch Retinal Artery Occlusion","Hemianopia","Leber Hereditary Optic Neuropathy","Acute Zonal Occult Outer Retinopathy",[25,26],"Optic Neuropathy",", Retinopathy","INTERVENTIONAL","DIAGNOSTIC",[30],"NA",{"count":32,"type":33},500,"ESTIMATED",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39},"DEVICE","LSFG-NAVI","laser-speckle blood flow of ocular arteries and veins",[40],"Laser Speckle Blood Flow Group",[42],{"measure":43,"description":44,"timeFrame":45},"Ocular Blood Flow","imaging the movement of blood through blood vessels in retina and optic nerve","1 day",[],"ALL","18 Years","99 Years",true,{"inclusion":52,"exclusion":53,"raw_text":54},[],[],"Controls:\n\nInclusion:\n\nNormal eye exam in last 2 years\n\nExclusion:\n\nCataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay. Any abnormalities of the retina or optic nerve that could affect metabolism of the retina outside of normal.\n\nSubjects with Inner Retina Defect:\n\nInclusion:\n\nDefined structural defect to include those with Ischemic optic neuropathy, branch retinal artery occlusion (BRAO), hemianopia or visual field defect that respects the vertical meridian, inherited mitochondrial optic neuropathies such as Leber's and Dominant Optic Neuropathy, other retinopathies or optic neuropathies.\n\nExclusion:\n\nCataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.\n\nSubjects with Outer Retinal Defect:\n\nInclusion:\n\nAZOOR (acute zonal occult outer retinopathy) or other focal or diffuse outer photoreceptor loss of function\n\nExclusion:\n\nCataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.\n\nThe 450 total is to allow for exclusion of some subjects or in the event that the enrolled subject blinks too much or cannot fixate on a visual target adequately to maintain the same eye position during the short imaging interval. We hope to have a total of 450 (50 controls and 400 patients)",[56,57],"ADULT","OLDER_ADULT",[59],{"facility":60,"status":8,"city":61,"state":62,"zip":63,"country":64,"contacts":65,"geoPoint":72},"University of Iowa Department of Ophthalmology","Iowa City","Iowa","52242","United States",[66],{"name":67,"role":68,"phone":69,"phoneExt":70,"email":71},"Denise L Rettig, MHA. MBA","CONTACT","319-356-2866","5849","denise-rettig@uiowa.edu",{"lat":73,"lon":74},41.66113,-91.53017,[76,80],{"name":77,"role":68,"phone":78,"email":79},"Julie K Nellis, BSN","319-356-8299","julie-nellis@uiowa.edu",{"name":81,"role":68,"phone":78,"email":82},"Jan M Full, BSN","jan-full@uiowa.edu",[84],{"name":85,"affiliation":60,"role":86},"Randy H Kardon, MD, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":90,"biomarkers":98},[91,92,93,94,95,25,96,97],"Acute zonal occult outer retinopathy","Dominant Optic Neuropathy","Hemianopsia","Ischemic optic neuropathy","Leber Hereditary Optic Atrophy","Retinal Arterial Branch Occlusion","Retinal Disorder",[],{"nct_id":4,"found":50,"summary":100,"prompt_version":109},{"design":101,"status":102,"heading":6,"summary":103,"follow_up":104,"word_count":105,"commitments":106,"compensation":107,"drugs_mentioned":108},"This is an interventional study with an enrollment goal of 500 participants. It is not specified if it is randomized or blinded.","completed","This study is testing a new device called LSFG-NAVI to look at the blood flow in your eyes. It aims to see if this device can better detect problems in the retina (the light-sensitive tissue at the back of your eye) compared to other vision tests. You might be able to join if you are between 18 and 99 years old and have certain eye conditions like Ischemic Optic Neuropathy (damage to the optic nerve from lack of blood flow) or Leber Hereditary Optic Neuropathy (an inherited vision loss condition). People with normal eye exams can also participate as a control group. The main goal is to measure ocular blood flow (blood flow in the eye) on the first day of the study.","Ocular blood flow is measured at 1 day, but further follow-up is not specified.",123,"Not specified in the trial record.","Not stated in the trial record.",[37],"v2"]