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Patient Comfort Following Intravitreal Injections Using Iheezo Versus Standard Anesthesia

CompletedPhase 4

Sponsor: Retina Consultants of Delmarva

Conditions: Macular Degeneration, Diabetic Retinopathy, Retinal Vein Occlusion (RVO)

Interventions: Iheezo, Lidocaine pledget

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Easton, Maryland, United States