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Efficacy of Mydriatic Drops in Premature Infants

Efficiency and Safety of Phenylephrine and Tropicamide Used in Premature Retinopathy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03448640
Enrollment
60
Registered
2018-02-28
Start date
2016-01-15
Completion date
2017-12-15
Last updated
2018-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinopathy of Prematurity

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.

Interventions

DRUGDrug used in the examination of premature infants.

to investigate side effects of eye drops used

Sponsors

Bulent Ecevit University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
32 Weeks to 34 Weeks
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The mean pupillary diameteran average of 1 yearwill be measured with a ruler after 60 minutes instillation of mydriatic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026