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Completed

NCT Number: NCT05880433

The Effects of Mydriatic Eye Drops in Retinopathy of Prematurity Examinations

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.

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Key information

Conditions

Retinopathy of Prematurity Analgesic Adverse Reaction Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Mydriasis Neonatal Disease Pupil Disorders Retinal Diseases

Age range

28 day–31 day

Sex eligibility

All sexes

Study type

Observational

Primary location

IstanbulTRH

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Babies born at gestational age less than 34 weeks and/or birth weight below 2000 grams.

Infants undergoing their first retinopathy examination.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. NIRS

    Time frame: 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.

    Absolute change in rScO2 after mydriatic eye drops instillation with NIRS

  2. Doppler US measurements

    Time frame: 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.

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

Secondary outcomes

  1. Changes in heart rate (beats per minute)

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

    Heart rate was recorded continuously, starting 60 minutes before and after mydriatic eye drop instillation.

  2. Changes in blood pressure

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

    Mean arterial pressure values was recorded for every 5 minutes, starting 60 minutes before and after mydriatic eye drop instillation,through study completion, an average of 2 hours.

  3. Changes in oxygen saturation.

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

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

Sponsors and collaborators

Lead sponsor

Istanbul Training and Research Hospital

Other Gov

Registry information

Official study title

The Effects of Mydriatic Eye Drops on Cerebral Blood Flow and Oxygenation in Retinopathy of Prematurity Examinations: A Prospective Observational Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 30, 2023
Registry last updated
May 30, 2023

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.

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