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Efficacy of Mydriatic Drops in Premature Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03448640
Recruitment Status : Completed
First Posted : February 28, 2018
Last Update Posted : February 28, 2018
Information provided by (Responsible Party):
Atilla Alpay, Bulent Ecevit University

Brief Summary:
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.

Condition or disease Intervention/treatment
Retinopathy of Prematurity Drug: Drug used in the examination of premature infants.

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Efficiency and Safety of Phenylephrine and Tropicamide Used in Premature Retinopathy
Actual Study Start Date : January 15, 2016
Actual Primary Completion Date : October 15, 2017
Actual Study Completion Date : December 15, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Tropicamide

Intervention Details:
  • Drug: Drug used in the examination of premature infants.
    to investigate side effects of eye drops used
    Other Name: Tropicamide and mydfline used

Primary Outcome Measures :
  1. The mean pupillary diameter [ Time Frame: an average of 1 year ]
    will be measured with a ruler after 60 minutes instillation of mydriatic

Information from the National Library of Medicine

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Ages Eligible for Study:   32 Weeks to 34 Weeks   (Child)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   neonatal
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
tertiary health center in the west Black Sea region

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.
Publications of Results:

Other Publications:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Atilla Alpay, Asociate Pofessor Atilla Alpay, Bulent Ecevit University Identifier: NCT03448640    
Other Study ID Numbers: BulentEU
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Retinal Diseases
Retinopathy of Prematurity
Eye Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action