Status:

COMPLETED

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

Lead Sponsor:

The University of Texas Medical Branch, Galveston

Conditions:

Light Sensitivity

Eligibility:

All Genders

Phase:

NA

Brief 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,...

Detailed Description

Pain management for Retinopathy of prematurity (ROP) screening focuses on pharmacological and non-pharmacological interventions during the actual eye examination. Management of pain related to increas...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

July 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2012

Estimated Enrollment :

28 Patients enrolled

Trial Details

Trial ID

NCT01860534

Start Date

July 1 2011

End Date

September 1 2012

Last Update

January 14 2016

Active Locations (1)

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1

University of Texas Medical Branch

Galveston, Texas, United States, 77555