Clinical trial NCT05880433: The Effects of Mydriatic Eye Drops in Retinopathy of Prematurity Examinations
Official title: The Effects of Mydriatic Eye Drops on Cerebral Blood Flow and Oxygenation in Retinopathy of Prematurity Examinations: A Prospective Observational Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Istanbul Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-05-30
Enrollment: 62
Sex: ALL
Minimum age (years): 28
Maximum age (years): 31
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: NIRS
timeFrame: 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.
measure: Doppler US measurements
timeFrame: 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:
measure: Changes in heart rate (beats per minute)
timeFrame: starting 60 minutes before and after mydriatic eye drop instillation,through study completion, an average of 2 hours.
measure: Changes in blood pressure
timeFrame: Starting 60 minutes before and after mydriatic eye drop instillation,through study completion, an average of 2 hours.
measure: Changes in oxygen saturation.
timeFrame: Starting 60 minutes before and after mydriatic eye drop instillation,through study completion, an average of 2 hours.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: IstanbulTRH
Study officials:
References: