Eye Shields for Infants After Dilated Exam

Children's Hospital Los Angeles

Status: Unknown

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

Treatments: Device: phototherapy eye shield

Study type: Interventional

Funder types: Other

Identifiers

NCT04519060

CHLA-20-00211

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 106 estimated patients

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

No eye shields after dilated eye exam

No Intervention group

Description:

Eye dilation for scheduled exam will be followed by routine clinical care.

Eye shields after dilated eye exam

Experimental group

Description:

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.

Treatment:

Device: phototherapy eye shield