Efficacy and Safety of Phenylephrine 2.5% with Cyclopentolate 0.5% for Retinopathy of Prematurity Screening in 1246 Eye Examinations

Neffendorf, James E; Mota, Peter M; Xue, Kanmin; Hildebrand, Göran Darius

doi:10.5301/ejo.5000540

Cited by 21 publications

(22 citation statements)

References 24 publications

(22 reference statements)

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“…One common complication of preterm birth is retinopathy of prematurity (ROP), a disease of the developing blood vessels on the retina that may lead to vision impairment or blindness. 2 The American Academy of Pediatrics (AAP) has published guidelines for ROP screening examinations that start at 4–6 weeks of age, focusing on infants born at less than 30 weeks gestational age or weighing less than 1500 g. 3,4 These examinations require administration of mydriatic ophthalmic drops to dilate the pupils and sometimes involve physical manipulation of the eye. Ocular administration of cyclopentolate alone or in combination with phenylephrine is the preferred drug used to induce pupil dilation in infants.…”

Section: Introductionmentioning

confidence: 99%

Systemic Absorption of Cyclopentolate and Adverse Events After Retinopathy of Prematurity Exams

Mitchell

Hall

Erickson

et al. 2016

Current Eye Research

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Purpose Preterm infants undergoing Retinopathy of Prematurity Eye Exams (ROPEE) may experience adverse events, possibly from systemic absorption of cyclopentolate. The purpose of this study was to analyze the association between adverse events and drug levels found in neonates undergoing ROPEE. Materials and Methods 25 infants were randomized into two groups during routine ROP screening: 5 infants for blood collection before mydriatic drops and 20 for blood collection 1 h after eye drops. Blood was collected onto dried blood spot cards, extracted, and analyzed for cyclopentolate and phenylephrine using liquid chromatography and mass spectrometry. Relationships between drug levels and adverse events were assessed. Results Cyclopentolate (range 6–53 ng/ml) was observed in 15 of 18 infants, while phenylephrine was not detected. Levels of cyclopentolate were significantly higher in infants who were on oxygen (p = 0.01). There was a significant association between cyclopentolate levels and gastric residuals in tube-fed infants not receiving oxygen (p = 0.01). Conclusions Cyclopentolate levels varied among preterm infants after ROPEE. Cyclopentolate was positively associated with increased gastric residuals. Underlying medical conditions requiring oxygen administration may affect absorption and metabolism of cyclopentolate. There is a need to predict infants at risk for high blood levels of cyclopentolate in order to prevent or treat adverse events after ROPEE.

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Section: Introductionmentioning

confidence: 99%

Systemic Absorption of Cyclopentolate and Adverse Events After Retinopathy of Prematurity Exams

Mitchell

Hall

Erickson

et al. 2016

Current Eye Research

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“…Cases of massive increases in blood pressure, cardiac arrhythmias, and even myocardial infarction have been documented after the administration of phenylephrine eye drops. These reports describe incidents that mainly occurred after the administration of high-dose eye drops 45. Generally, a healthy cornea presents a physical barrier and the extent of drug penetration is determined by its condition.…”

Section: Drug Classesmentioning

confidence: 99%

Systemic side effects of eye drops: a pharmacokinetic perspective

Farkouh¹,

Frigo²,

Czejka

2016

OPTH

175

131

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When administering eye drops, even when completely correctly applied, several routes of absorption are possible and excess amounts can sometimes cause an unwanted systemic bioavailability of the drops when not completely absorbed into the eye. Furthermore, the concentration of active ingredients in such medicinal preparations is usually very high, so that despite the correct application of the recommended dose, considerable amounts may be absorbed in an unwanted manner through various routes. Children are subject to a much higher risk of systemic side effects because ocular dosing is not weight adjusted and physiological development (eg, liver status) differs from that of adults. There is a lack of information about pediatric dosing in the current literature. This review summarizes the most important clinically relevant systemic side effects that may occur during ophthalmic eye treatments. In this review, we discuss general pharmacokinetic considerations as well as the advantages, disadvantages, and consequences of administering drugs from some important drug groups to the eye.

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“…Several studies have evaluated mydriatic regimens for preterm infants [9-12]. However, adverse events remain a concern [8], especially for cyclopentolate, which is contraindicated for children under 1 year of age in several European countries because of possible severe central nervous system side effects.…”

Section: Discussionmentioning

confidence: 99%

“…Medians, means, and standard deviation (SD) were used to describe quantitative variables. Considering the results of a previous comparative study [9] in adults, and assuming a primary event rate (i.e., high-quality mydriasis) of 95%, a sample size of 80 patients (40 per treatment group) was required to establish noninferiority with 80% power and a one-sided 0.025 level of significance. Noninferiority was declared if the lower limit of the two-sided 95% confidence interval (CI) for the absolute difference between the rates of high-quality mydriasis in the two treatment groups was above the prespecified noninferiority margin of –15%.…”

Section: Methodsmentioning

confidence: 99%

“…While relatively innocuous in adults, mydriatic agents can lead to systemic side effects, such as cardiovascular complications in infants, as a large proportion of the eye drop volume may be absorbed from the conjunctival and nasal mucosa [4-8]. Several studies have evaluated mydriatic regimens for preterm infants [9-12]. Bolt et al [13] showed that an eye drop combination of 2.5% phenylephrine and 0.5% tropicamide could achieve a sufficient mydriasis without systemic side effects.…”

Section: Introductionmentioning

confidence: 99%

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Ophthalmic Insert versus Eye Drops for Mydriasis in Neonates: A Randomized Clinical Trial

Bremond-Gignac¹,

Jacqz-Aigrain

Abdoul³

et al. 2018

Neonatology

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Background: Eye drop treatment routinely used to obtain mydriasis prior to fundoscopy in neonates requires repeated instillations of mydriatic agents that can lead to systemic side effects. Objectives: The aim of this study was to compare the mydriatic efficacy and tolerance of administration of phenylephrine and tropicamide via the ophthalmic insert Mydriasert® versus standard eye drop treatment in neonates. Methods: In this prospective, single-blinded, noninferiority study, 80 hospitalized neonates (age < 18 months) requiring bilateral fundus examination were randomized to receive eye drops (repeated instillations of 2.5% phenylephrine and 0.5% tropicamide) or the insert. The primary outcome was mydriasis suitable for fundoscopy 75 min after mydriatic agent introduction (T75). Results: Mydriasis was successfully achieved in both eyes at T75 in 97.5% (n = 39/40) of the insert group patients versus 90% (n = 36/40) receiving eye drops (between-group difference 7.5%, demonstrating noninferiority). Mydriasis remained stable in 60.0% of patients (n = 24/40) in the insert group versus 15% (n = 6/40) in the eye drop group (p < 0.0001). The insert group required fewer nursing interventions than the eye drop group (p = 0.0001). Mean blood pressure were significantly higher in the insert versus the eye drop group (p < 0.0001 and p = 0.0003, respectively); mean heart rate was not significantly different between the groups (p = 0.37). In the insert group, 2 patients reported an adverse event (bradycardia, n = 1, and gastroesophageal reflux, n = 1; both appeared to be related to neonate pathology). Conclusions: The degree of mydriasis achieved with Mydriasert® was noninferior to that obtained with eye drops. The insert appears to be safe to use in neonates without a history of increased vagal tone or gastrointestinal reflux.

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Efficacy and Safety of Phenylephrine 2.5% with Cyclopentolate 0.5% for Retinopathy of Prematurity Screening in 1246 Eye Examinations

Cited by 21 publications

References 24 publications

Systemic Absorption of Cyclopentolate and Adverse Events After Retinopathy of Prematurity Exams

Systemic Absorption of Cyclopentolate and Adverse Events After Retinopathy of Prematurity Exams

Systemic side effects of eye drops: a pharmacokinetic perspective

Ophthalmic Insert versus Eye Drops for Mydriasis in Neonates: A Randomized Clinical Trial

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