Cool vs Room-temperature Artificial Tears

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetic Retinopathy With Macular Edema of Both Eyes (Diagnosis) CYSTOID MACULAR EDEMA Central Retinal Vein Occlusion With Macular Edema Disease Dry Eye Sensation Exudative Age-Related Macular Degeneration, Unspecified Eye Eye Diseases Eye Manifestations Eye Pain Macular Degeneration Macular Edema Neurologic Manifestations Ocular Surface Disease Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Signs and Symptoms

Age range

18 year–105 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Iowa Hospitals & Clinics - Department of Ophthalmology

Iowa City, Iowa, 52242, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Refresh Plus Preservative-free Lubricant Eye Drops

Drug

Refresh Plus Preservative-free Lubricant Eye Drops at either 4 or 25 degree Celsius

Primary outcomes

The Efficacy of Cooled Versus Room Temperature Artificial Tears in Reducing Post Intravitreal Injection Ocular Discomfort as Measured by Pain Scale Survey.

Time frame: with 72 hours of the intervention

The level of subjectively reported pain scale from 1 to 10, where 1 is minimal pain and 10 is extreme pain

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Registry information

Official study title

Randomized Controlled Study of Cooled Versus Room-Temperature Artificial Tears for Reducing Surface Irritation Following Intravitreal Injection

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Apr 27, 2023
Registry last updated: Mar 4, 2025

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.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting