The Effects of Mydriatic Eye Drops in Retinopathy of Prematurity Examinations

Completed

• Conditions: Retinopathy of Prematurity; Mydriasis; Neonatal Disease; Analgesic Adverse Reaction
• Interventions: Device: NIRS(INVOS 5100; Covidien Somanetics, Troy, MI

• Registration Number: NCT05880433
• Lead Sponsor: Istanbul Training and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-01
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30
• Status Verified: 2023-05
• Study First Submitted: 2023-05-09
• Study First Submitted QC: 2023-05-19
• Last Update Submitted: 2023-05-19
• Study First Posted: 2023-05-30
• Last Update Posted: 2023-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
After Eye drop instillation	NIRS(INVOS 5100; Covidien Somanetics, Troy, MI	The same participiants investigated after eye drop instillation
Before Eye drop instillation	NIRS(INVOS 5100; Covidien Somanetics, Troy, MI	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.

Primary Outcome Measures

Name	Time	Method
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.	Absolute change in rScO2 after mydriatic eye drops instillation with NIRS
Doppler US measurements	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 Outcome Measures

Name	Time	Method
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.	Heart rate was recorded continuously, starting 60 minutes before and after mydriatic eye drop instillation.
Changes in blood pressure	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.
Changes in oxygen saturation.	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.

Trial Locations

Locations (1)

IstanbulTRH; 🇹🇷 Istanbul, Turkey