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OpenTrials
Completed

NCT Number: NCT07779356

Patient Comfort Following Intravitreal Injections Using Iheezo Versus Standard Anesthesia

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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Key information

Conditions

Macular Degeneration Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Embolism and Thrombosis Endocrine System Diseases Eye Diseases Retinal Degeneration Retinal Diseases Retinal Vein Occlusion Retinal Vein Occlusion (RVO) Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Retina Consultants of Delmarva

Easton, Maryland, 21601, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Anyone receiving bilateral same day intravitreal injections as standard care

Exclusion criteria

  • Inability to complete post-injection survey
  • History of receiving Iheezo

Treatment and study plan

Iheezo

Drug

Iheezo applied prior to injection

Lidocaine pledget

Drug

Standard anesthesia in practice, as proparacaine drops plus lidocaine pledget

Primary outcomes

  1. Discomfort after injection

    Time frame: 2 minutes to 24 hours after injection

    Rated 0-10 in each eye

Sponsors and collaborators

Lead sponsor

Retina Consultants of Delmarva

Other

Collaborators

  • Harrow Inc

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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