CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
eye coversbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01860534
NCT01860534N/ACompleted

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

The University of Texas Medical Branch, Galveston·interventional·Posted May 22, 2013·Updated Jan 14, 2016

In Brief

A clinical study evaluating eye covers for Light Sensitivity. Completed, enrolled 28 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 22, 2013
Enrollment StartJul 1, 2011
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 13.1 years ago

Interventions

eye coversbehavioral

The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.