Phase 4 N=124 Randomized Single-blind Prevention

Cool vs Room-temperature Artificial Tears

Diabetic Retinopathy With Macular Edema of Both Eyes (Diagnosis) · Central Retinal Vein Occlusion With Macular Edema · Exudative Age-Related Macular Degeneration, Unspecified Eye · Cystoid Macular Edema · Ocular Surface Disease

Bottom Line

View on ClinicalTrials.gov: NCT05832996 ↗

Enrolled (actual)

124

Serious AEs

0.0%

Results posted

Mar 2025

Primary outcome: Primary: The Efficacy of Cooled Versus Room Temperature Artificial Tears in Reducing Post Intravitreal Injection Ocular Discomfort as Measured by Pain Scale Survey. — 2.21; 1.95 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Refresh Plus Preservative-free Lubricant Eye Drops (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Iowa
Primary completion: Jul 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY The Efficacy of Cooled Versus Room Temperature Artificial Tears in Reducing Post Intravitreal Injection Ocular Discomfort as Measured by Pain Scale Survey.	2.21; 1.95	—

Summary

Background and Objective: To evaluate the efficacy of cooled versus room temperature artificial tears in reducing post intravitreal injection (IVI) ocular discomfort. Patients and Methods: Patients receiving IVI were randomized to either cooled or room temperature tears intervention groups. Both groups rated their ocular discomfort following IVI before intervention and again after administration of cooled or room temperature tears.

Eligibility Criteria

Inclusion Criteria

Patients were eligible if they were receiving standard intravitreal injections for their exudative age-related macular degeneration, cystoid macular edema, diabetic macular edema, proliferative diabetic retinopathy, retinal vein occlusion with macular edema, or retinal neovascularization.

Exclusion Criteria

Inability or lack of willingness to participate in the study
Active ocular infection including infectious uveitis
First time receiving intravitreal injection
Those who reported never having ocular discomfort following intravitreal injections on the pre-injection questionnaire
Less than 18 years of age

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Data sourced from ClinicalTrials.gov (NCT05832996). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.