Comparative Evaluation of Patient Comfort Following Intravitreal Injections Using Iheezo Versus Standard Anesthesia in a Private Retina Practice
| Registry | NCT07779356 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, single group, masking: none, treatment |
| Enrollment | 50 (Actual) |
| Sponsor | Retina Consultants of Delmarva (Other); collaborators: Harrow Inc |
| Conditions | Macular Degeneration, Diabetic Retinopathy, Retinal Vein Occlusion (RVO) |
| Interventions | Iheezo, Lidocaine pledget (Drug) |
| Dates | start 2026-05-20, primary completion 2026-08-07, completion 2026-08-11, first posted 2026-08-21, last updated 2026-08-21 |
| Locations | 1 site in United States |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Iheezo | Experimental | Drug: Iheezo | Standard anesthesia plus iheezo prior to injection |
| No iheezo | Placebo comparator | Drug: Lidocaine pledget | Standard anesthesia alone |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Anyone receiving bilateral same day intravitreal injections as standard care Exclusion Criteria: * Inability to complete post-injection survey * History of receiving Iheezo
| Facility | City | Country | Status |
|---|---|---|---|
| Retina Consultants of Delmarva | Easton, Maryland | United States |