{"type":"trials","record":{"id":41708,"source_id":"clinicaltrials-gov","external_id":"NCT05542381","title":"The Role of Loteprednol in Reducing Post-Intravitreal Injection Related Pain","brief_summary":"Patients are already receiving an intravitreal injection as a standard of care, but they are consenting to receiving a loteprednol drop following the intravitreal injection. This clinical trial is studying the role of loteprednol (corticosteroid) in reducing pain following intravitreal injections for patients with age-related macular degeneration. As of now, there is no definitive pain management technique following intravitreal injections. Loteprednol is a corticosteroid widely used in ophthalmology to treat pain and inflammation, however, it has not been studied as a treatment for pain following intravitreal injections. Our overall goal is to manage pain to improve quality of care after intravitreal injections. Participants will be given either loteprednol, or artificial tears following one visit for an intravitreal injection to test how effective loteprednol is in pain reduction. Pain levels will be assessed by asking participants over the phone about their pain from a scale of 0 to 10 at three different times over a 1-week period. Artificial tear and medication usage will also be tracked over a 1-week period.","overall_status":"Completed","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Virginia Polytechnic Institute and State University","enrollment":64,"countries":["United States"],"start_date":"2022-12-22","completion_date":"2025-05-01","last_update_date":"2025-09-19","source_url":"https://clinicaltrials.gov/study/NCT05542381","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","comparator":"Artificial tears","organization":"Virginia Polytechnic Institute and State University","interventions":["Loteprednol Etabonate Ophthalmic Gel [Lotemax]","Refresh Lubricant Eye Drops [Artificial Tears]"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Post-Intravitreal Injection Pain — 2-hour Post-Intravitreal Injection","Post-Intravitreal Injection Pain — 1-day Post-Intravitreal Injection","Post-Intravitreal Injection Pain — 1-week Post-Intravitreal Injection","Analgesic Medication Use — 2-hour Post-Intravitreal Injection","Analgesic Medication Use — 1-day Post-Intravitreal Injection","Analgesic Medication Use — 1-week Post-Intravitreal Injection","Artificial Tear Use — 2-hour Post-Intravitreal Injection","Artificial Tear Use — 1-day Post-Intravitreal Injection","Artificial Tear Use — 1-week Post-Intravitreal Injection"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · TRIPLE","source_has_results":false},"controlled_terms":["Age-Related Macular Degeneration","Loteprednol Etabonate Ophthalmic Gel [Lotemax]","Refresh Lubricant Eye Drops [Artificial Tears]"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"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:nct05542381","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2022-12-22 to 2025-05-01","comparator":"Artificial tears","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":"2026-09-25T06:20:47.857Z","intervention":["Loteprednol Etabonate Ophthalmic Gel [Lotemax]","Refresh Lubricant Eye Drops [Artificial Tears]"],"participants":64,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · 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":["Post-Intravitreal Injection Pain — 2-hour Post-Intravitreal Injection","Post-Intravitreal Injection Pain — 1-day Post-Intravitreal Injection","Post-Intravitreal Injection Pain — 1-week Post-Intravitreal Injection","Analgesic Medication Use — 2-hour Post-Intravitreal Injection","Analgesic Medication Use — 1-day Post-Intravitreal Injection","Analgesic Medication Use — 1-week Post-Intravitreal Injection","Artificial Tear Use — 2-hour Post-Intravitreal Injection","Artificial Tear Use — 1-day Post-Intravitreal Injection","Artificial Tear Use — 1-week Post-Intravitreal Injection"],"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: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"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/41708","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}