{"type":"trials","record":{"id":41852,"source_id":"clinicaltrials-gov","external_id":"NCT06174181","title":"Preventive TREatment of Dry Eye in Patients Receiving Repeated Intravitreal Injections for Age-related Macular Degeneration","brief_summary":"Age-related macular degeneration (AMD) is the 1st cause of visual impairment after the age of 50. Its most aggressive form, wet AMD, requires regular intravitreal injections (IVI) spaced 4 to 8 weeks apart usually depending on the treatment regimen and the patient's response. The IVI procedure requires a double disinfection with periocular and conjunctival cutaneous povidone-iodine. Antiseptic agents such as povidone iodine are a highly likely factor in the development of dry eye syndrome. Clinical data have demonstrated the abrasive and toxic effects of their use on the ocular surface, especially with repeated exposure (Saedon H, Nosek J, Phillips J. Ocular surface effects of repeated application of povisoden-iodine in patients receiving frequent intravitreal injections. Cutaneous and Ocular Toxicology. 2017;36(4):343-6.). The IVIS study coordinated by Prof. Dot reported impaired ocular surface and quality of life immediately after IVI. The authors suggest 3 levels of action to improve immediate tolerance: (i) improve the basal status of the ocular surface, (ii) reduce the contact time with povidone-iodine which could be toxic to the ocular surface and (iii) improve immediate post-IVI treatment. (Verrecchia S et al. A prospective multicentre study of intravitreal injections and ocular surface in 219 patients: IVIS study. Acta Ophthalmol. 2021 Mar 18). This study is part of the extension of the IVIS study. IVIs are effective and do not currently present a therapeutic alternative. However, their role in the development or exacerbation of dry eye is still poorly evaluated although millions of IVIs are performed each year worldwide (1.3 million in France in 2019). In addition, discomfort after injection is one of the factors that limit adherence to long-term IVI treatment, some patients fearing this repeated act. We propose in this bicentric, prospective, randomized, parallel group study, to evaluate in this context the impact of the continuous consideration of the risk of dry eye. The expected results are the objective improvement of dry eye indicators, comfort and quality of life of patients, all aimed at optimizing the adherence of our patients to their AMD treatment.","overall_status":"Completed","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Direction Centrale du Service de Santé des Armées","enrollment":42,"countries":["France"],"start_date":"2023-10-09","completion_date":"2024-11-14","last_update_date":"2025-02-25","source_url":"https://clinicaltrials.gov/study/NCT06174181","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":"TREDIA","age_range":"18 Years","comparator":null,"organization":"Direction Centrale du Service de Santé des Armées","interventions":["Preservative-free ophtalmic lubricant emulsion","Routine treatment"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Mean tear break-up time (TBUT) at the end of the study — 24 weeks","ocular surface alteration after 24 weeks — 24 weeks"],"design_description":"RANDOMIZED · PARALLEL · PREVENTION · TRIPLE","source_has_results":false},"controlled_terms":["Dry Eye Syndromes","Age-Related Macular Degeneration","Preservative-free ophtalmic lubricant emulsion","Routine treatment"],"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:nct06174181","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2023-10-09 to 2024-11-14","comparator":null,"confidence":"structured-source","population":"ALL · 18 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":"2026-09-25T06:20:47.880Z","intervention":["Preservative-free ophtalmic lubricant emulsion","Routine treatment"],"participants":42,"study_design":"RANDOMIZED · PARALLEL · PREVENTION · TRIPLE","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":["Mean tear break-up time (TBUT) at the end of the study — 24 weeks","ocular surface alteration after 24 weeks — 24 weeks"],"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/41852","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}