Cool vs Room-temperature Artificial Tears

University of Iowa

Status and phase: Completed; Phase 4

Conditions: Exudative Age-Related Macular Degeneration, Unspecified Eye; Dry Eye Sensation; Diabetic Retinopathy With Macular Edema of Both Eyes (Diagnosis); Central Retinal Vein Occlusion With Macular Edema; Eye Pain; Cystoid Macular Edema; Ocular Surface Disease

Treatments: Drug: Refresh Plus Preservative-free Lubricant Eye Drops

Study type: Interventional

Funder types: Other

Identifiers

NCT05832996

202201397

Details and patient eligibility

About

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.

Enrollment: 124 patients

Sex: All

Ages: 18 to 105 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

124 participants in 2 patient groups

Cooled artificial tear group

Experimental group

Description:

Stored at 4 degree Celsius

Treatment:

Drug: Refresh Plus Preservative-free Lubricant Eye Drops

Room temperature artificial tear group

Active Comparator group

Description:

Stored at 25 degree Celsius

Treatment:

Drug: Refresh Plus Preservative-free Lubricant Eye Drops