N/A N=28 Randomized Supportive Care

"Eye Protection After Mydriatic Use for ROP Screening: Impact on Vitals Signs and Pain Scores"

Light Sensitivity

Bottom Line

View on ClinicalTrials.gov: NCT01860534 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2016

Primary outcome: Primary: Heart Rate — 154; 154; 152; 163 Beats per minutes

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: eye covers (Behavioral)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: The University of Texas Medical Branch, Galveston
Primary completion: Sep 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Heart Rate	154; 154; 152; 163; 154; 164	—
SECONDARY Respiratory Rate	54; 47; 54; 52; 55; 50	—
SECONDARY Oxygen Percent Saturation	98; 98; 98; 98; 98; 98	—
SECONDARY Pain	0.4; 0.3; 0.1; 1.1; 0.2; 1	—

Summary

Pupillary dilation induced by mydriatic agents during Retinopathy of Prematurity exams can persist for hours. Despite regular use of eye protection for mydriatic-induced light sensitivity for infants, children and adults, eye protection after mydriasis has not been addressed in neonates. This study examines the use of eye patches to protect the dilated pupil from light exposure and their impact on vital signs and pain scores. prevents tachycardia, tachypnea and discomfort in neonates after ROP screening.

Eligibility Criteria

Inclusion Criteria

All infants with gestational age at birth of 30 weeks or less or with birth weight less than 1500g undergoing their first ROP exam in the Infant Special Care Unit (ISCU) at UTMB.

Exclusion Criteria

Infants were excluded if they had any congenital malformation or syndrome; a history of eye surgery or were receiving inotropics medications.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01860534). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.