Eye Shields for Infants After Dilated Exam
An Eye-opener: The Impact of Eye Shields for Infants After Dilated Exam
1 other identifier
interventional
106
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2020
CompletedFirst Posted
Study publicly available on registry
August 19, 2020
CompletedStudy Start
First participant enrolled
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedMarch 12, 2021
March 1, 2021
8 months
May 17, 2020
March 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Number of stress events amongst covariates
4-6 hours (from first dose of eye dilating medication to four hours after last dose)
Study Arms (2)
No eye shields after dilated eye exam
NO INTERVENTIONEye dilation for scheduled exam will be followed by routine clinical care.
Eye shields after dilated eye exam
EXPERIMENTALEye 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Chronological age 0-12 months
- Infants who require dilated eye exams
- Parent or legal guardian consent/permission granted
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- BSN
Study Record Dates
First Submitted
May 17, 2020
First Posted
August 19, 2020
Study Start
February 1, 2021
Primary Completion
October 1, 2021
Study Completion
December 1, 2021
Last Updated
March 12, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share