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COMPLETED
NCT07779356
PHASE4

Patient Comfort Following Intravitreal Injections Using Iheezo Versus Standard Anesthesia

Sponsor: Retina Consultants of Delmarva

View on ClinicalTrials.gov

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.

Official title: Comparative Evaluation of Patient Comfort Following Intravitreal Injections Using Iheezo Versus Standard Anesthesia in a Private Retina Practice

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-05-20

Completion Date

2026-08-11

Last Updated

2026-08-21

Healthy Volunteers

No

Interventions

DRUG

Iheezo

Iheezo applied prior to injection

DRUG

Lidocaine pledget

Standard anesthesia in practice, as proparacaine drops plus lidocaine pledget

Locations (1)

Retina Consultants of Delmarva

Easton, Maryland, United States