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Eye Shields for Infants After Dilated Exam

Sponsor
Children's Hospital Los Angeles (Other)
Overall Status
Recruiting
CT.gov ID
NCT04519060
Collaborator
(none)
106
Enrollment
1
Location
2
Arms
10
Anticipated Duration (Months)
10.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: phototherapy eye shield
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
106 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Eye-opener: The Impact of Eye Shields for Infants After Dilated Exam
Actual Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
No Intervention: No eye shields after dilated eye exam

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

Device: 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.
Other Names:
  • phototherapy eye protector
  • phototherapy eye mask

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of stress events [4-6 hours (from first dose of eye dilating medication to four hours after last dose)]

      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.

    Secondary Outcome Measures

    1. Number of stress events amongst covariates [4-6 hours (from first dose of eye dilating medication to four hours after last dose)]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 1 Year
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital Los Angeles Los Angeles California United States 90027

    Sponsors and Collaborators

    • Children's Hospital Los Angeles

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Maxine Ogbaa, BSN, Children's Hospital Los Angeles
    ClinicalTrials.gov Identifier:
    NCT04519060
    Other Study ID Numbers:
    • CHLA-20-00211
    First Posted:
    Aug 19, 2020
    Last Update Posted:
    Mar 12, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Maxine Ogbaa, BSN, Children's Hospital Los Angeles
    eye shield
    eye protector
    eye patch
    eye mask
    phototherapy
    Additional relevant MeSH terms:
    Eye Diseases
    Retinopathy of Prematurity
    Infant, Newborn, Diseases

    Study Results

    No Results Posted as of Mar 12, 2021