Efficacy of Mydriatic Drops in Premature Infants

Because of the neonatologists reported that some infants had suffered from vomiting, bradycardia, hypotonia, and aspiration risk about 30-60 minutes after the fundus examination in the intensive care unit. The investigators observed the pupil dilation effects and side effects of tipple instillation of phenylephrine 2.5% plus tropicamide 0.5% ophthalmic drop combination which the investigators routinely used in ROP examination.

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Key information

Conditions

Retinopathy of Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Retinal Diseases

Age range

32 week–34 week

Sex eligibility

All sexes

Study type

Observational

About this study

Purpose: To determine effect and vital change after topical application of phenylephrine 2.5% and tropicamide 0.5% three times for retinopathy of prematurity (ROP) examination in preterm infants.

Methods: Pupillary diameter, blood pressure, pulse rate, and oxygen saturation were monitored before, and after up to 24 hours 60 ROP screening examinations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Infants who were first ROP examinations
infants born before 32 weeks.

Exclusion criteria

Developmental ocular and/or systemic anomalies.
Drug use that can affect vital values
Unstable general condition
Food intolerance
Recurrent vomiting.

Treatment and study plan

Drug used in the examination of premature infants.

Drug

to investigate side effects of eye drops used

Other names: Tropicamide and mydfline used

Primary outcomes

The mean pupillary diameter

Time frame: an average of 1 year

will be measured with a ruler after 60 minutes instillation of mydriatic

Sponsors and collaborators

Lead sponsor

Bulent Ecevit University

Other

Registry information

Official study title

Efficiency and Safety of Phenylephrine and Tropicamide Used in Premature Retinopathy

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Feb 28, 2018
Registry last updated: Feb 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed