The Effects of Mydriatic Eye Drops in Retinopathy of Prematurity Examinations

NCT ID: NCT05880433

Last Updated: 2023-05-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 62 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2022-11-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

NIRS(INVOS 5100; Covidien Somanetics, Troy, MI

Intervention Type: 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

The same participiants investigated after eye drop instillation

NIRS(INVOS 5100; Covidien Somanetics, Troy, MI

Intervention Type: 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.

Interventions

NIRS(INVOS 5100; Covidien Somanetics, Troy, MI

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 28 Days
• Maximum Eligible Age: 31 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Didem Arman

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IstanbulTRH

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

IstanbulTRH-DArman-001

Identifier Type: -

Identifier Source: org_study_id