Eye Shields for Infants After Dilated Exam

NCT ID: NCT04519060

Last Updated: 2021-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-12-31

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.

Conditions

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Infant, Newborn, Disease Pain Retinopathy of Prematurity Eye Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Eye shields after dilated eye exam

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.

Group Type EXPERIMENTAL

phototherapy eye shield

Intervention Type DEVICE

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.

No eye shields after dilated eye exam

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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phototherapy eye shield

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.

Intervention Type DEVICE

Other Intervention Names

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phototherapy eye protector phototherapy eye mask

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
Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Maxine Ogbaa

BSN

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Maxine Ogbaa, BSN

Role: CONTACT

323-361-2531

Heidi Machen, PHN, BSN

Role: CONTACT

323-361-2531

Facility Contacts

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Maxine Ogbaa, BSN

Role: primary

323-361-2531

Heidi Machen, PHN, BSN

Role: backup

323-361-2531

Other Identifiers

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CHLA-20-00211

Identifier Type: -

Identifier Source: org_study_id

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