Clinical trial NCT05832996: Cool vs Room-temperature Artificial Tears
Official title: Randomized Controlled Study of Cooled Versus Room-Temperature Artificial Tears for Reducing Surface Irritation Following Intravitreal Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: 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
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: The Efficacy of Cooled Versus Room Temperature Artificial Tears in Reducing Post Intravitreal Injection Ocular Discomfort as Measured by Pain Scale Survey.
timeFrame: with 72 hours of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics - Department of Ophthalmology
state: Iowa
Study officials:
affiliation: University of Iowa
name: Douglas Jin, MD
role: PRINCIPAL_INVESTIGATOR
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