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Patient Comfort Following Intravitreal Injections Using Iheezo Versus Standard Anesthesia

NCT07779356 — Phase 4, Completed, 50 participants, Retina Consultants of Delmarva

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

RegistryNCT07779356
StatusCompleted
PhasePhase 4
Study typeInterventional; randomized, single group, masking: none, treatment
Enrollment50 (Actual)
SponsorRetina Consultants of Delmarva (Other); collaborators: Harrow Inc
ConditionsMacular Degeneration, Diabetic Retinopathy, Retinal Vein Occlusion (RVO)
InterventionsIheezo, Lidocaine pledget (Drug)
Datesstart 2026-05-20, primary completion 2026-08-07, completion 2026-08-11, first posted 2026-08-21, last updated 2026-08-21
Locations1 site in United States

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
IheezoExperimentalDrug: IheezoStandard anesthesia plus iheezo prior to injection
No iheezoPlacebo comparatorDrug: Lidocaine pledgetStandard anesthesia alone
  • Iheezo (Drug): Iheezo applied prior to injection
  • Lidocaine pledget (Drug): Standard anesthesia in practice, as proparacaine drops plus lidocaine pledget

+Outcome measures

Primary outcomes

  • Discomfort after injection [2 minutes to 24 hours after injection]: Rated 0-10 in each eye

+Eligibility

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

+Locations (1)

FacilityCityCountryStatus
Retina Consultants of DelmarvaEaston, MarylandUnited States

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