Eye Shields for Infants After Dilated Exam

Study Overview
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Brief Summary
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The eyes of hospitalized infants are often assessed by dilated exam, and there is evidence that infants experience post-exam stress. Investigators will evaluate whether eye shields for infants after dilated eye exam lessen stress and discomfort.

Detailed Description
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Neonatal eye examinations are the standard of best practice in pediatrics. In the acute clinical setting, infants' eyes are inspected for eye development, defect, and disease. There is anecdotal and clinical evidence that infants experience stress after eye dilation. Investigators will evaluate whether eye shields for infants after dilated eye exam lessen stress and discomfort.

Official Title
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An Eye-opener: The Impact of Eye Shields for Infants After Dilated Exam

Conditions
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Infant, Newborn, Disease, Pain, Retinopathy of Prematurity, Eye Diseases

Intervention / Treatment
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* Device: phototherapy eye shield


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronological age 0-12 months Infants who require dilated eye exams Parent or legal guardian consent/permission granted Exclusion Criteria: More than a two-week interval between dilated eye exams Prior or ongoing medical treatment or therapy for the eye(s) Functional blindness diagnosed by eye exam

Ages Eligible for Study
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Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No eye shields after dilated eye exam<br>Eye dilation for scheduled exam will be followed by routine clinical care. | |
| Experimental: Eye shields after dilated eye exam<br>Eye dilation for scheduled exam will be followed by routine clinical care and the application of eye shields. They will be worn until four (4) hours after the last dose of dilating eye drops. | Device: phototherapy eye shield<br>* Phototherapy eye shields will be applied to the eyes of infants dilated for scheduled eye exam. They will be worn until four (4) hours after the last dose of dilating eye drops.<br>* Other names: phototherapy eye mask;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of stress events | The primary outcome will be measured by the count of apneas and bradycardias (stress events) experienced by the infant during the period of eye dilation without eye shields as compared to the total stress events experienced when dilated eyes are covered with eye shields. | 4-6 hours (from first dose of eye dilating medication to four hours after last dose) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of stress events amongst covariates | The secondary outcome measure will be abstracted from covariate data (e.g., infant gestational age at birth, post-natal age, weight, and ventilation status) to assess the influence of covariables on the response to eye shields as an intervention to lessen stress and discomfort in hospitalized infants after dilated eye exam. | 4-6 hours (from first dose of eye dilating medication to four hours after last dose) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eye shield, eye protector, eye patch, eye mask, phototherapy