The Effects of Mydriatic Eye Drops in Retinopathy of Prematurity Examinations

NCT05880433 | Completed

• 1 other identifier: IstanbulTRH-DArman-001
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Retinopathy of prematurity (ROP) is a retinal disorder of preterm neonates and a potential cause of blindness. As early diagnosis and treatment preserve vision, very low birth weight infants must be screened for ROP. Mydriatic eye drop administration is essential to perform funduscopic evaluations. The most commonly used mydriatic drops for pupil dilatation are 0.5-1.0% tropicamide and/or 0.5-1.0% phenylephrine or 0.2-1.0% cyclopentolate. Phenylephrine, an alpha-1 sympathomimetic agonist, is readily absorbed from conjunctival mucosa and has a potent systemic vasopressor effect. Tropicamide causes cycloplegia by inhibition of ciliary muscle contraction and has a short acting para-sympatholytic effect. Systemic absorption of mydriatic eye drops has been associated with cardiovascular, respiratory and gastrointestinal adverse effects. Systemic side effects include apnea, desaturation, increased heart rate and blood pressure, delayed gastric emptying, and feeding intolerance. The data about the effects of mydriatics on cerebral blood flow and tissue oxygenation are sparse. Cerebral blood flow autoregulation depends in part on the adrenergic and cholinergic control of cerebral vasculature, but whether mydriatics have an effect on cerebral haemodynamics is unknown. Near-infrared spectroscopy and Doppler ultrasonography (US) are non-invasive methods commonly used for neuromonitorization in NICUs. The regional blood flow changes measured using Doppler US have been reported to be associated with cerebral oxygenation and indicate a high correlation with NIRS in newborns. The aim of this study was to evaluate the effects of mydriatic eye drops on cerebral oxygenation and blood flow in preterm infants by NIRS and Doppler US.

Conditions

Retinopathy of Prematurity; Mydriasis; Neonatal Disease; Analgesic Adverse Reaction

Keywords

Cerebral blood flow; Cerebral oxygenation; Mydriatic eye drops; Doppler ultrasonography; Retinopathy of prematurity; NIRS; Neonate

Outcome Measures

Primary Outcomes (2)

• NIRS

  Absolute change in rScO2 after mydriatic eye drops instillation with NIRS

  Data were started to get recorded 60 minutes before the instillation of eye drops for pupil dilation. The recording was continued uninterruptedly till 1 hour after the instillation through study completion, an average of 2 hours.

• Doppler US measurements

  Absolute change in MCA blood flow after mydriatic eye drops instillation with Doppler USG

  The initial and second assessment were conducted before the application and at the 60th minute of instillation of the first drop, respectively - an average of 2 hours.

Secondary Outcomes (3)

• Changes in heart rate (beats per minute)

  starting 60 minutes before and after mydriatic eye drop instillation,through study completion, an average of 2 hours.

• Changes in blood pressure

  Starting 60 minutes before and after mydriatic eye drop instillation,through study completion, an average of 2 hours.

• Changes in oxygen saturation.

  Starting 60 minutes before and after mydriatic eye drop instillation,through study completion, an average of 2 hours.

Study Arms (2)

Before Eye drop instillation

For pupil dilatation, one drop of 2.5% phenylephrine hydrochloride and 0.5% tropicamide was instilled three times at 5 minute intervals, 1 hour before the exam. All infants were fed 1 hour before instillation of drops and infants were swaddled before the procedure.

Device: NIRS(INVOS 5100; Covidien Somanetics, Troy, MI

After Eye drop instillation

The same participiants investigated after eye drop instillation

Device: NIRS(INVOS 5100; Covidien Somanetics, Troy, MI

Interventions

NIRS(INVOS 5100; Covidien Somanetics, Troy, MI DEVICE

NIRS (Near Infrared Spectroscopy) is a non-invasive, bedside device that measures the concentration of oxygenated and deoxygenated hemoglobin in tissue, providing information about tissue oxygenation. Its working mechanism is based on the ability of light with wavelengths between 700-1000 nm to penetrate up to 8 cm into the skin and brain tissue. It offers continuous information about tissue oxygenation in different regions using probes attached to the skin. While pulse oximeters indicate arterial oxygen saturation, they are insufficient in detecting tissue-level hypoxia. Therefore, NIRS, being a painless method, is frequently used in the monitoring of newborns in the intensive care unit.

After Eye drop instillation; Before Eye drop instillation

Eligibility Criteria

• Age: 28 Days - 31 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Sixty two infants with a gestational age below 34 weeks and/or with a birth weight of less than 2000 g. were included in the study. The infants who underwent the initial retinopathy screening exam and did not need any respiratory support at the time of the examination were included. The neonates with congenital anomaly, sepsis, hemodynamic instability and intraventricular hemorrhage were excluded.

You may qualify if:

• Babies born at gestational age less than 34 weeks and/or birth weight below 2000 grams.
• Infants undergoing their first retinopathy examination.

You may not qualify if:

• Congenital anomaly
• Continued mechanical ventilation support
• Having pain from a different cause and/or requiring concurrent analgesic use
• Sedation analgesia administered within the last 24 hours
• Hemodynamically unstable
• Intraventricular hemorrhage, neurological dysfunction
• Receiving anticonvulsant therapy.

Sponsors & Collaborators

• Istanbul Training and Research Hospital: lead

Study Sites (1)

IstanbulTRH

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Retinopathy of Prematurity; Mydriasis; Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pupil Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 30, 2023
• Study Start: May 1, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: May 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)