{"type":"trials","record":{"id":41372,"source_id":"clinicaltrials-gov","external_id":"NCT07481500","title":"Speculum-Free Intravitreal Injection Using Cotton-Tipped Applicator Retraction: Pain, Procedure Time, Patient Satisfaction, and Safety","brief_summary":"This randomized controlled trial compares two techniques for eyelid retraction during intravitreal injection (IVI) of anti-VEGF agents: the standard wire eyelid speculum (Group A) versus cotton-tipped applicator retraction (Group B) in patients with neovascular AMD, diabetic macular edema, or retinal vein occlusion. The study evaluates four outcomes: (1) patient pain perception measured by a 10-cm visual analogue scale immediately after injection; (2) procedure duration from retraction device placement to removal; (3) patient satisfaction assessed by a 5-item Likert scale; and (4) safety including rates of subconjunctival hemorrhage, corneal abrasion, endophthalmitis, and intraocular pressure elevation. A novel syringe cap technique using the Terumo 31G insulin syringe plastic cap as an injection-site marker (3.5 mm for pseudophakic eyes, 5.0 mm for phakic eyes from the limbus) is employed in both groups, replacing the traditional caliper. Randomization is stratified by diagnosis and prior injection history using permuted block randomization (block sizes 4 and 6). The target sample size is 120 patients (60 per group) at Walailak University Hospital, Nakhon Si Thammarat, Thailand.","overall_status":"Not Yet Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Jakkrit Juhong","enrollment":120,"countries":[],"start_date":"2026-10-01","completion_date":"2027-08-01","last_update_date":"2026-09-08","source_url":"https://clinicaltrials.gov/study/NCT07481500","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Not Yet Recruiting. 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":"IVI-RETRACT","age_range":"18 Years","comparator":"Eyelid Speculum (Group A)","organization":"Walailak University","interventions":["Eyelid Speculum Retraction","Cotton-Tipped Applicator Retraction"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Pain Perception — Immediately after intravitreal injection (Day 0)","Procedure Duration — During intravitreal injection procedure (Day 0)","Patient Satisfaction — 15-30 minutes after intravitreal injection (Day 0)","Procedure-Related Complications — Day 0, Day 1, and Week 4 post-injection"],"design_description":"RANDOMIZED · PARALLEL · SUPPORTIVE CARE · SINGLE","source_has_results":false},"controlled_terms":["Neovascular Age-Related Macular Degeneration (nAMD)","Diabetic Macular Edema","Retinal Vein Occlusion","Intravitreal Injections","Eyelid Speculum Retraction","Cotton-Tipped Applicator Retraction"],"relevance_confidence":60,"source_quality_score":100,"freshness_score":100,"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:nct07481500","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-10-01 to 2027-08-01","comparator":"Eyelid Speculum (Group A)","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":"2026-09-25T06:20:47.800Z","intervention":["Eyelid Speculum Retraction","Cotton-Tipped Applicator Retraction"],"participants":120,"study_design":"RANDOMIZED · PARALLEL · SUPPORTIVE CARE · SINGLE","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":["Pain Perception — Immediately after intravitreal injection (Day 0)","Procedure Duration — During intravitreal injection procedure (Day 0)","Patient Satisfaction — 15-30 minutes after intravitreal injection (Day 0)","Procedure-Related Complications — Day 0, Day 1, and Week 4 post-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":["Source terminology contains: age-related macular degeneration.","Source terminology supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"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/41372","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}