{"type":"trials","record":{"id":41991,"source_id":"clinicaltrials-gov","external_id":"NCT05441072","title":"Validation of Bulbicam for DR- and AMD-patients","brief_summary":"Aim * To investigate repeatability and stability of the six OTH-related Bulbicam tests in patients suffering from a) Diabetic retinopathy (DR), b) Age related macular degeneration (AMD) and matched healthy controls (HC). * To compare Bulbicam and the Standard Method on measurements of Visual Field and Pupil * To contribute to the establishment of normal range for DR and AMD patients with different degree in the disease development related to the Bulbicam tests. * To contribute to the establishment of normal range for a normal population without eye-disease related to the Bulbicam tests. Study population The study consists of the following three study populations: 1) Patients suffering from DR of both genders above 18 years of age with different disease degree; 2) Patients suffering from AMD of both genders above 18 years of age with different disease degree; 3) Gender- and age-matched HC without any eye diseases. Study procedure Participants, who fulfil the inclusion criteria; do not meet any of the exclusion criteria and willing to give informed consent to participate will receive an appointment for starting the study. The Bulbicam examination will be performed twice a day with a rest period of one hour between each registration. This procedure will be repeated the following two days. All demographic data, social factors and history of disease will be recorded at screening. Additionally, the quality of life (QoL) questionnaires EQ-5D-5L developed by EuroQol will be recorded initially as individual baseline values. The Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be used for measuring and classifying the tolerability and toxicity at the end of each day of investigation.","overall_status":"Completed","phases":[],"study_type":"OBSERVATIONAL","sponsor":"Meddoc","enrollment":64,"countries":["Norway"],"start_date":"2022-12-19","completion_date":"2023-06-15","last_update_date":"2024-05-22","source_url":"https://clinicaltrials.gov/study/NCT05441072","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":"2026-09-25T01:25:30.378222+00:00","last_seen_at":"2026-09-25T06:20:47.789+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"18 Years to 80 Years","comparator":null,"organization":"Meddoc","interventions":["BulbiCam"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Visual Field — 0 hours","Visual Field — 2 hours","Visual Field — 4 hours","Visual Field — 24 hours","Visual Field — 26 hours","Visual Field — 28 hours","Ptosis — 0 hours","Ptosis — 2 hours","Ptosis — 4 hours","Ptosis — 24 hours","Ptosis — 26 hours","Ptosis — 28 hours"],"design_description":null,"source_has_results":false},"controlled_terms":["Diabetic Retinopathy","Age-Related Macular Degeneration","BulbiCam"],"relevance_confidence":60,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Source terminology contains: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct05441072","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2022-12-19 to 2023-06-15","comparator":null,"confidence":"structured-source","population":"ALL · 18 Years to 80 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":"2026-09-25T06:20:47.904Z","intervention":["BulbiCam"],"participants":64,"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":["Visual Field — 0 hours","Visual Field — 2 hours","Visual Field — 4 hours","Visual Field — 24 hours","Visual Field — 26 hours","Visual Field — 28 hours","Ptosis — 0 hours","Ptosis — 2 hours","Ptosis — 4 hours","Ptosis — 24 hours","Ptosis — 26 hours","Ptosis — 28 hours"],"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":["Source terminology contains: age-related macular degeneration.","Source terminology supplies longevity context: age-related.","Study type is explicitly identified as OBSERVATIONAL."],"matched_fields":["controlled terminology","controlled context","study type"],"relevance_score":60,"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/41991","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}