Cool vs Room-temperature Artificial Tears

Phase 4

Completed

• Conditions: Ocular Surface Disease; Central Retinal Vein Occlusion With Macular Edema; Eye Pain; Cystoid Macular Edema; Dry Eye Sensation; Diabetic Retinopathy With Macular Edema of Both Eyes (Diagnosis); Exudative Age-Related Macular Degeneration, Unspecified Eye
• Interventions: Drug: Refresh Plus Preservative-free Lubricant Eye Drops

• Registration Number: NCT05832996
• Lead Sponsor: University of Iowa

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-06
• Study First Submitted: 2023-03-14
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-16
• Last Update Submitted: 2023-04-16
• Study First Posted: 2023-04-27
• Last Update Posted: 2023-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Room temperature artificial tear group	Refresh Plus Preservative-free Lubricant Eye Drops	Stored at 25 degree Celsius
Cooled artificial tear group	Refresh Plus Preservative-free Lubricant Eye Drops	Stored at 4 degree Celsius

Primary Outcome Measures

Name	Time	Method
The efficacy of cooled versus room temperature artificial tears in reducing post intravitreal injection ocular discomfort as measured by pain scale survey.	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

Trial Locations

Locations (1)

University of Iowa Hospitals & Clinics - Department of Ophthalmology; 🇺🇸 Iowa City, Iowa, United States