{"type":"trials","record":{"id":41713,"source_id":"clinicaltrials-gov","external_id":"NCT02395757","title":"Microperimetry and Eye Progressing From Stage 3 to Stage 4 Age-related Macular Degeneration (AMD)","brief_summary":"Age-related macular degeneration (AMD) is an acquired retinal pathology affecting the central region of the retina responsible for discrimination between high spatial frequencies (reading), colour vision and the central visual field. The loss of visual acuity which occurs with the onset of AMD significantly affects patients' quality of life. In developed countries, AMD is the leading cause of vision impairment for people aged over 50 years. Its prevalence in Europe in people aged over 65 years is 3.3%. In France, around 2 million people suffer from this disease. In the first stage of the disease it is known as age-related maculopathy (ARM). This early form of the disease can develop into intermediate AMD (stage 3 of the AREDS classification) and then advanced AMD (stage 4 AREDS), which can be atrophic or exudative. In cases of exudative AMD, the intravitreal administration of anti-VEGF drugs can limit the disease's progression. It is therefore vital to adopt a strategy to assess the stage of the disease and provide the appropriate care management at the earliest possible stage. This is even more important for patients with advanced AMD in one eye and intermediate AMD in the fellow eye, as the risk of the fellow eye progressing to the advanced stage within 5 years is between 35% and 53%. Microperimetry is a promising new diagnostic method which combines measurements of light sensitivity, loss of fixation and the anatomy of the retina. It offers a new approach to the functional assessment of retinal damage in patients with AMD, as it precisely correlates anatomical and functional modifications by measuring the loss of sensitivity and macular fixation. It has been shown that the more advanced the patient's AMD is, the further the parameters measured by microperimetry are from the norm. The investigators want to assess the MAIA™ as a means of screening for AMD progression in patients with a high risk of progressing to a more advanced stage (patients presenting one eye with advanced AMD and a fellow eye with stage 3 AMD according to the AREDS classification). The research hypothesis for our proposed study is that the parameters measured using microperimetry will already show abnormal results in the study eye prior to progressing to a more advanced stage of the disease. The use of these microperimetric parameters as predictor of progression would therefore make it possible to screen eyes likely to develop from intermediate to advanced AMD at an earlier stage, and subsequently provide patients who need it with earlier follow-up, preventive treatment or adapted, personalized rehabilitation as appropriate.","overall_status":"Completed","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Hospices Civils de Lyon","enrollment":182,"countries":["France"],"start_date":"2015-09-01","completion_date":"2020-01-08","last_update_date":"2025-09-12","source_url":"https://clinicaltrials.gov/study/NCT02395757","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":"PREVISION","age_range":"50 Years","comparator":null,"organization":"Hospices Civils de Lyon","interventions":["MAIA™ (Centervue, Padova, Italy; distributed in France by EDC Lamy, Carvin, France)"],"registry_source":"ClinicalTrials.gov","outcome_measures":["The sensitivity of the microperimetric parameter(s) and combination(s) of parameters according to patient status at fin…","The specificity of the microperimetric parameter or combination of parameters with the highest level of sensitivity — 2…","The positive predictive value of the microperimetric parameter or combination of parameters with the highest level of s…","The negative predictive value of the microperimetric parameter or combination of parameters with the highest level of s…","The sensitivity of the microperimetric parameters associated with the parameters from other ophthalmological examinatio…","The specificity of the microperimetric parameters associated with the parameters from other ophthalmological examinatio…","The sensitivity of the microperimetric parameters or combinations of parameters for the sub-group of eyes presenting re…","The specificity of the microperimetric parameters or combinations of parameters for the sub-group of eyes presenting re…"],"design_description":"NA · SINGLE GROUP · DIAGNOSTIC · NONE","source_has_results":false},"controlled_terms":["Stage 3 Age Related Macular Degeneration (AREDS Classification)","MAIA™ (Centervue, Padova, Italy; distributed in France by EDC Lamy, Carvin, France)"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Title contains controlled term: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct02395757","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2015-09-01 to 2020-01-08","comparator":null,"confidence":"structured-source","population":"ALL · 50 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":"2026-09-25T06:20:47.858Z","intervention":["MAIA™ (Centervue, Padova, Italy; distributed in France by EDC Lamy, Carvin, France)"],"participants":182,"study_design":"NA · SINGLE GROUP · DIAGNOSTIC · NONE","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":["The sensitivity of the microperimetric parameter(s) and combination(s) of parameters according to patient status at fin…","The specificity of the microperimetric parameter or combination of parameters with the highest level of sensitivity — 2…","The positive predictive value of the microperimetric parameter or combination of parameters with the highest level of s…","The negative predictive value of the microperimetric parameter or combination of parameters with the highest level of s…","The sensitivity of the microperimetric parameters associated with the parameters from other ophthalmological examinatio…","The specificity of the microperimetric parameters associated with the parameters from other ophthalmological examinatio…","The sensitivity of the microperimetric parameters or combinations of parameters for the sub-group of eyes presenting re…","The specificity of the microperimetric parameters or combinations of parameters for the sub-group of eyes presenting re…"],"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":["Title contains controlled term: age-related macular degeneration.","Abstract contains controlled term: age-related macular degeneration.","Title supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","title 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/41713","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}