Diabetic Retinopathy, Macular Degeneration, Retinal Vein Occlusion (RVO)
Conditions
Brief 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.
Interventions
DRUGIheezo
Iheezo applied prior to injection
DRUGLidocaine pledget
Standard anesthesia in practice, as proparacaine drops plus lidocaine pledget
Sponsors
Retina Consultants of Delmarva
Harrow Inc
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Anyone receiving bilateral same day intravitreal injections as standard care
Exclusion criteria
* Inability to complete post-injection survey * History of receiving Iheezo
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Discomfort after injection | 2 minutes to 24 hours after injection | Rated 0-10 in each eye |
Countries
United States
Outcome results
None listed