{"type":"trials","record":{"id":41766,"source_id":"clinicaltrials-gov","external_id":"NCT03882606","title":"Implantation of SML in Patients With Dry Age-related Macular Degeneration and Myopic Maculopathy","brief_summary":"Age-related macular degeneration (AMD) is the leading cause of irreversible vision loss in developed countries among people over 50 years of age. Myopic maculopathy is also an important cause of irreversible vision loss. Reduced near visual acuity is still a major problem with all forms of AMD and myopic maculopathy. Various intraocular lenses for near vision (IOLs) or telescopic systems have been described but are not widely accepted and almost all solutions require phakic status of the eye and are implanted during cataract surgery. Therefore, these devices are not appropriated for pseudophakic AMD and myopic maculopathy patients. Scharioth Macula Lens (SML, Medicontur) is a magnifying intraocular lens for pseudophakic patients implanted in the ciliary sulcus in one eye of each patient. The implant has a bifocal optic, with a central 1.5mm diameter optical zone equivalent to +10D add and a peripheral zone optically neutral. The implantation of the add-on SML can improve the near visual acuity of pseudophakic patients with AMD and myopic maculopathy without impairing their distance visual acuity. The principal objective is to compare the near visual acuity, the far visual acuity and the self-reported vision health status before and after the SML implantation.","overall_status":"Completed","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Consorci Sanitari de Terrassa","enrollment":3,"countries":["Spain"],"start_date":"2019-05-22","completion_date":"2023-09-01","last_update_date":"2025-06-17","source_url":"https://clinicaltrials.gov/study/NCT03882606","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":"50 Years","comparator":null,"organization":"Consorci Sanitari de Terrassa","interventions":["Scharioth Macula Lens (SML, Medicontur)"],"registry_source":"ClinicalTrials.gov","outcome_measures":["change in near visual acuity — will be performed at day 1, 1 week, 1, 3 and 6 months after surgery","change in VFQ25 score — will be performed at day 1, 1 week, 1, 3 and 6 months after surgery","change in far visual acuity — will be performed at day 1, 1 week, 1, 3 and 6 months after surgery"],"design_description":"NA · SINGLE GROUP · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Age-Related Macular Degeneration","Lens, Intraocular","Myopic Maculopathy","Scharioth Macula Lens (SML, Medicontur)"],"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:nct03882606","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2019-05-22 to 2023-09-01","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":"2026-09-25T06:20:47.868Z","intervention":["Scharioth Macula Lens (SML, Medicontur)"],"participants":3,"study_design":"NA · SINGLE GROUP · TREATMENT · 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":["change in near visual acuity — will be performed at day 1, 1 week, 1, 3 and 6 months after surgery","change in VFQ25 score — will be performed at day 1, 1 week, 1, 3 and 6 months after surgery","change in far visual acuity — will be performed at day 1, 1 week, 1, 3 and 6 months after surgery"],"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.","Source terminology contains: age-related macular degeneration.","Title supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","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/41766","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}