Cool vs Room-temperature Artificial Tears

Study Overview
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Brief Summary
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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.

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

Conditions
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Eye Pain, 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

Intervention / Treatment
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* Drug: Refresh Plus Preservative-free Lubricant Eye Drops


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 105 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of cooled versus room temperature artificial tears in reducing post intravitreal injection ocular discomfort as measured by pain scale survey. | The level of subjectively reported pain scale from 1 to 10, where 1 is minimal pain and 10 is extreme pain | with 72 hours of the intervention |