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Completed
NCT07779356
Patient Comfort Following Intravitreal Injections Using Iheezo Versus Standard Anesthesia
Conditions: Macular Degeneration, Diabetic Retinopathy, Retinal Vein Occlusion (RVO)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 50
Sponsor: Retina Consultants of Delmarva
Location: Retina Consultants of Delmarva Easton Maryland
Summary
Prospective comparative clinical study.
One hundred eyes of 50 patients were included. All patients received bilateral same-day intravitreal injections, with Iheezo administered to only one randomly selected eye and standard topical anesthesia administered to the contralateral control eye. Ocular discomfort was assessed using a 0-10 numeric rating scale at 2 minutes, 1 hour, 6-12 hours, and 24 hours following injection. The primary longitudinal analysis used a linear mixed-effects model incorporating treatment group, assessment time, and treatment-by-time interaction as fixed effects and patient as a random effect. Between-group differences at individual time points were evaluated using Welch two-sample comparisons with Holm adjustment for multiple comparisons. Patient-level mean discomfort across the four assessments was also compared between groups.
Eligibility Criteria
Inclusion Criteria:
* Anyone receiving bilateral same day intravitreal injections as standard care
Exclusion Criteria:
* Inability to complete post-injection survey
* History of receiving Iheezo
Source: ClinicalTrials.gov (NCT07779356). StuddyBuddy aggregates publicly available trial information.