Eye Shields for Infants After Dilated Exam

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Eye Diseases; Retinopathy of Prematurity; Infant, Newborn, Disease
• Intervention / Treatment: Device: phototherapy eye shield

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 Type: Interventional
• Enrollment (Anticipated): 106
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maxine Ogbaa, BSN; Phone Number: 323-361-2531; Email: mogbaa@chla.usc.edu
• Study Contact Backup: Name: Heidi Machen, PHN, BSN; Phone Number: 323-361-2531; Email: hmachen@chla.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Recruiting
      • Children's Hospital Los Angeles
      • Contact: Maxine Ogbaa, BSN; Phone Number: 323-361-2531; Email: mogbaa@chla.usc.edu
      • Contact: Heidi Machen, PHN, BSN; Phone Number: 323-361-2531; Email: hmachen@chla.usc.edu
      • Principal Investigator: Maxine Ogbaa, BSN
      • Sub-Investigator: Heidi Machen, PHN, BSN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Children's Hospital Los Angeles

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2021
• Primary Completion (ANTICIPATED): October 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: May 17, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (ACTUAL): August 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 12, 2021
• Last Update Submitted That Met QC Criteria: March 10, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: phototherapy; eye mask; eye shield; eye protector; eye patch
• Additional Relevant MeSH Terms: Retinal Diseases; Infant, Premature, Diseases; Eye Diseases; Retinopathy of Prematurity; Infant, Newborn, Diseases
• Other Study ID Numbers: CHLA-20-00211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No