Cool vs Room-temperature Artificial Tears

Sponsor

University of Iowa (Other)

Overall Status

Completed

CT.gov ID

NCT05832996

Collaborator

(none)

124

Enrollment

Location

Arms

4.2

Actual Duration (Months)

29.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Dry Eye Sensation Eye Pain	Drug: Refresh Plus Preservative-free Lubricant Eye Drops	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 1, 2022

Actual Primary Completion Date :

Jul 1, 2022

Actual Study Completion Date :

Jul 6, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cooled artificial tear group Stored at 4 degree Celsius	Drug: Refresh Plus Preservative-free Lubricant Eye Drops Refresh Plus Preservative-free Lubricant Eye Drops at 4 degree Celsius
Active Comparator: Room temperature artificial tear group Stored at 25 degree Celsius	Drug: Refresh Plus Preservative-free Lubricant Eye Drops Refresh Plus Preservative-free Lubricant Eye Drops at 4 degree Celsius

Arm

Intervention/Treatment

Experimental: Cooled artificial tear group

Stored at 4 degree Celsius

Drug: Refresh Plus Preservative-free Lubricant Eye Drops

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

Active Comparator: Room temperature artificial tear group

Stored at 25 degree Celsius

Drug: Refresh Plus Preservative-free Lubricant Eye Drops

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 105 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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