Central Retinal Vein Occlusion With Macular Edema, Cystoid Macular Edema, Diabetic Retinopathy With Macular Edema of Both Eyes (Diagnosis), Dry Eye Sensation, Exudative Age-Related Macular Degeneration, Unspecified Eye, Eye Pain, Ocular Surface Disease
Conditions
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.
Interventions
DRUGRefresh Plus Preservative-free Lubricant Eye Drops
Refresh Plus Preservative-free Lubricant Eye Drops at either 4 or 25 degree Celsius
Sponsors
University of Iowa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 105 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cooled Artificial Tear Group Stored at 4 degree Celsius
Refresh Plus Preservative-free Lubricant Eye Drops: Refresh Plus Preservative-free Lubricant Eye Drops at 4 degree Celsius | 48 |
| Room Temperature Artificial Tear Group Stored at 25 degree Celsius
Refresh Plus Preservative-free Lubricant Eye Drops: Refresh Plus Preservative-free Lubricant Eye Drops at 4 degree Celsius | 61 |
| Total | 109 |
Baseline characteristics
| Characteristic | Room Temperature Artificial Tear Group | Total | Cooled Artificial Tear Group |
|---|---|---|---|
| Age, Continuous | 68.3 years STANDARD_DEVIATION 15.4 | 68.7 years STANDARD_DEVIATION 15.7 | 69.1 years STANDARD_DEVIATION 15.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 59 Participants | 106 Participants | 47 Participants |
| Sex: Female, Male Female | 45 Participants | 77 Participants | 32 Participants |
| Sex: Female, Male Male | 16 Participants | 32 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 61 |
| other Total, other adverse events | 0 / 48 | 0 / 61 |
| serious Total, serious adverse events | 0 / 48 | 0 / 61 |
Outcome results
Primary
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
Time frame: with 72 hours of the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cooled Artificial Tear Group | The Efficacy of Cooled Versus Room Temperature Artificial Tears in Reducing Post Intravitreal Injection Ocular Discomfort as Measured by Pain Scale Survey. | 2.21 score on a scale | Standard Deviation 0.2 |
| Room Temperature Artificial Tear Group | The Efficacy of Cooled Versus Room Temperature Artificial Tears in Reducing Post Intravitreal Injection Ocular Discomfort as Measured by Pain Scale Survey. | 1.95 score on a scale | Standard Deviation 0.2 |