Clinical trial NCT03448640: Efficacy of Mydriatic Drops in Premature Infants
Official title: Efficiency and Safety of Phenylephrine and Tropicamide Used in Premature Retinopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinopathy of Prematurity
Lead sponsor: Bulent Ecevit University
Sponsor class: OTHER
First posted: 2018-02-28
Enrollment: 60
Sex: ALL
Minimum age (years): 32
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: tertiary health center in the west Black Sea region

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The mean pupillary diameter
timeFrame: an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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