[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07425106":3,"trial-entities:NCT07425106":82,"trial-summary:NCT07425106":87},{"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":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":36,"secondary_outcomes":47,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":54,"eligibility_criteria":55,"std_ages":62,"locations":65,"central_contacts":75,"overall_officials":76,"references":80,"see_also_links":81},"NCT07425106","Pro00111488_1","Comparative Study of High Performance Low-Cost Optical Coherence Tomography (Stage 1B, 2 and 3)","Comparative Study of High Performance Low-Cost Optical Coherence Tomography","ENROLLING_BY_INVITATION","2027-02","2026-02","2026-02-25","2026-02-13","Duke University","OTHER",null,"The purpose of this study is to complete performance testing of our custom optical coherence tomography (OCT) device to verify it can deliver retinal images of similar quality to a commercial OCT device. We will then add an angle-resolved low coherence interferometry (a\u002FLCI module) to the device to make measurements of retinal tissue structure.","There is some evidence that certain changes in retinal structures could be an indicator of Alzheimer's disease (AD). We are developing a new technology that combines optical coherence tomography (OCT) and angle-resolved low coherence interferometry (a\u002FLCI) to make light scattering measurements of retinal tissue structure. The first objective of this study is to compare performance characteristics of our custom OCT instrument to a commercial OCT instrument. Once we have optimized our device, the second objective will be to use the custom OCT-a\u002FLCI device to identify retinal structure changes that could be possible AD biomarkers.\n\nFor this study, the team will recruit volunteers to attend one study visit that is about 30 minutes long. For arm 1A (registered under NCT05530460), this visit will include examination with our custom OCT instrument, followed by examination with a commercial OCT system. For arms 1B and 2\u002F3, the visit will include examination with the custom OCT-a\u002FLCI instrument.\n\nThis study will recruit participants with Alzheimer's disease and healthy controls.",[19,20],"Optical Coherence Tomography of Retina","Alzheimer Disease",[],"INTERVENTIONAL","BASIC_SCIENCE",[25],"NA",{"count":27,"type":28},82,"ESTIMATED",[30],{"type":31,"name":32,"description":32,"armGroupLabels":33},"DEVICE","retinal imaging with low-cost OCT-a\u002FLCI device",[34,35],"Performance Testing of OCT-a\u002FLCI (1B)","Retinal Morphology (2\u002F3)",[37,41,44],{"measure":38,"description":39,"timeFrame":40},"Number of Participants with Acceptable OCT Image Quality as Measured by Low-Cost OCT Device","measured by: ability to see clearly defined and recognizable structures of the retina with the low-cost OCT device.","during study procedures (30 minutes)",{"measure":42,"description":43,"timeFrame":40},"RNFL Thickness","Thickness of retinal nerve fiber layer, measured in microns",{"measure":45,"description":46,"timeFrame":40},"GCL Thickness","Thickness of ganglion cell layer, measured in microns.",[48],{"measure":49,"description":50,"timeFrame":40},"Contrast-to-Noise Ratio (CNR)","Measure of OCT image quality comparing level of image contrast to level of background noise. CNR = (mean of signal of region of interest \\[i.e., retina\\] - mean of background noise) divided by square root of (the square of the standard deviation of the region of interest + the square of the standard deviation of the background noise). Therefore, CNR is unitless.","ALL","18 Years","85 Years",true,{"inclusion":56,"exclusion":58,"raw_text":61},[57],"able to provide informed consent",[59,60],"potentially confounding ocular conditions, such as: glaucoma, current corneal injury, retinal damage, diabetes, corrected distance visual acuity worse than 20\u002F40","eyes that have had intraocular surgery or retinal surgery, other than cataract surgery","All Participants:\n\nInclusion Criteria:\n\n* able to provide informed consent\n\nExclusion Criteria:\n\n* potentially confounding ocular conditions, such as: glaucoma, current corneal injury, retinal damage, diabetes, corrected distance visual acuity worse than 20\u002F40\n* eyes that have had intraocular surgery or retinal surgery, other than cataract surgery\n\nParticipants with Alzheimer's Disease:\n\nInclusion:\n\n\\- mild cognitive impairment (MCI) or dementia due to Alzheimer's disease, confirmed by A\u002FT\u002FN classification\n\nHealthy Controls:\n\nExclusion:\n\n\\- has a memory or other neurodegenerative diagnosis (including mild cognitive impairment, Parkinson's disease, Alzheimer's disease, traumatic brain injury, post-traumatic stress disorder)\n\nIf two eyes satisfy the inclusion \u002F exclusion criteria, both eyes will be included in the study. If only one eye satisfies the criteria, only the qualifying eye will be included in the study.",[63,64],"ADULT","OLDER_ADULT",[66],{"facility":67,"city":68,"state":69,"zip":70,"country":71,"geoPoint":72},"Duke University Medical Center","Durham","North Carolina","27710","United States",{"lat":73,"lon":74},35.99403,-78.89862,[],[77],{"name":78,"affiliation":13,"role":79},"Adam Wax, Ph.D.","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":83,"biomarkers":86},[84,85],"Alzheimer's Disease","Mild cognitive disorder",[],{"nct_id":4,"found":88,"summary":15,"prompt_version":15},false]