{"type":"trials","record":{"id":31991,"source_id":"clinicaltrials-gov","external_id":"NCT04112667","title":"Functionally Validated Structural Endpoints for Early AMD","brief_summary":"Delayed rod-mediated dark adaptation (RMDA), or delayed recovery of vision in a dark environment, is a functional biomarker (i.e., risk factor) for early age-related macular degeneration (AMD). This research plan is designed to elucidate the structural (anatomical) basis of this visual deficit using cellular- and subcellular level imaging of the retina and its supporting tissues in living people. An accurate map and timeline of structure-function relationships in persons tested for night vision will result in functionally validated structural endpoints for early AMD trials, as well as define major biologic effects for development into future treatments.","overall_status":"Completed","phases":[],"study_type":"OBSERVATIONAL","sponsor":"Cynthia Owsley","enrollment":556,"countries":["United States"],"start_date":"2019-10-07","completion_date":"2024-10-31","last_update_date":"2025-09-26","source_url":"https://clinicaltrials.gov/study/NCT04112667","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:16:23.954312+00:00","last_seen_at":"2026-09-25T06:20:47.789+00:00","metadata":{"sex":"ALL","acronym":"ALSTAR2","age_range":"20 Years","comparator":null,"organization":"University of Alabama at Birmingham","interventions":["Normal Macular Health","Early Macular Degeneration","Young Normals"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Rod-mediated dark adaptation — Measured at baseline enrollment","Rod-mediated dark adaptation — Measured at 3 years after baseline enrollment","incident age-related macular degeneration (AMD) or progression of AMD using multimodal imaging — Measured at baseline e…","incident age-related macular degeneration (AMD) or progression of AMD using multimodal imaging — Measured at 3 years af…","Light sensitivity as measured by microperimetry and perimetry — Measured at baseline enrollment","Light sensitivity as measured by microperimetry and perimetry — Measured at 3 years after baseline enrollment","Photopic and mesopic acuity — Measured at baseline enrollment","Photopic and mesopic acuity — Measured at 3 years after baseline enrollment","Photopic and mesopic contrast sensitivity — Measured at baseline enrollment","Photopic and mesopic contrast sensitivity — Measured at 3 years after baseline enrollment"],"design_description":null,"source_has_results":false},"controlled_terms":["Age-related Macular Degeneration","Aging","Normal Macular Health","Early Macular Degeneration","Young Normals"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":85,"publication_state":"published","match_explanation":"Abstract contains controlled term: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct04112667","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2019-10-07 to 2024-10-31","comparator":null,"confidence":"structured-source","population":"ALL · 20 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:20:47.856Z","intervention":["Normal Macular Health","Early Macular Degeneration","Young Normals"],"participants":556,"study_design":"OBSERVATIONAL","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Rod-mediated dark adaptation — Measured at baseline enrollment","Rod-mediated dark adaptation — Measured at 3 years after baseline enrollment","incident age-related macular degeneration (AMD) or progression of AMD using multimodal imaging — Measured at baseline e…","incident age-related macular degeneration (AMD) or progression of AMD using multimodal imaging — Measured at 3 years af…","Light sensitivity as measured by microperimetry and perimetry — Measured at baseline enrollment","Light sensitivity as measured by microperimetry and perimetry — Measured at 3 years after baseline enrollment","Photopic and mesopic acuity — Measured at baseline enrollment","Photopic and mesopic acuity — Measured at 3 years after baseline enrollment","Photopic and mesopic contrast sensitivity — Measured at baseline enrollment","Photopic and mesopic contrast sensitivity — Measured at 3 years after baseline enrollment"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"vision-aging","is_published":true,"match_reasons":["Abstract contains controlled term: age-related macular degeneration.","Source terminology contains: age-related macular degeneration.","Abstract supplies longevity context: aging, age-related.","Study type is explicitly identified as OBSERVATIONAL."],"matched_fields":["abstract","controlled terminology","abstract context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Vision ageing","slug":"vision-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/31991","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}