Recruiting

Observational Study

Sponsor:

Children's Hospital Los Angeles

Code:

NCT04519060

Conditions

Infant, Newborn, Disease

Pain

Retinopathy of Prematurity

Eye Diseases

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

phototherapy eye shield

Study Details

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.

Conditions

Infant, Newborn, Disease

Pain

Retinopathy of Prematurity

Eye Diseases

Study ID

NCT04519060

Start date

Feb 1, 2021

Status verified date

Mar, 2021

Completion date

Dec, 2021

Anticipated

Primary completion date

Oct, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

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 Design

Enrollment

106 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Number of stress events [ Time Frame: 4-6 hours (from first dose of eye dilating medication to four hours after last dose) ]

Central Contacts and Locations

Central contacts

Maxine Ogbaa, BSN

323-361-2531mogbaa@chla.usc.edu

Heidi Machen, PHN, BSN

323-361-2531hmachen@chla.usc.edu

Locations

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Maxine Ogbaa, BSN

323-361-2531mogbaa@chla.usc.edu

Heidi Machen, PHN, BSN

323-361-2531hmachen@chla.usc.edu

Principal Investigator:

Maxine Ogbaa, BSN

More Information

Sponsor

Children's Hospital Los Angeles

Last update posted

Mar 12, 2021

Last verified

Mar, 2021

Keywords

  • eye shield
  • eye protector
  • eye patch
  • eye mask
  • phototherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Hospital Los Angeles on 2021-03-12.