Efficacy of Mydriatic Drops in Premature Infants

Retinopathy of Prematurity Clinical Trial

Official title:

Efficiency and Safety of Phenylephrine and Tropicamide Used in Premature Retinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03448640
• Other study ID #: BulentEU
• Status: Completed
• Phase: N/A
• First received: February 15, 2018
• Last updated: February 27, 2018
• Start date: January 15, 2016
• Est. completion date: December 15, 2017

Study information

• Verified date: February 2018
• Source: Bulent Ecevit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Because of the neonatologists reported that some infants had suffered from vomiting, bradycardia, hypotonia, and aspiration risk about 30-60 minutes after the fundus examination in the intensive care unit. The investigators observed the pupil dilation effects and side effects of tipple instillation of phenylephrine 2.5% plus tropicamide 0.5% ophthalmic drop combination which the investigators routinely used in ROP examination.

Description:

Purpose: To determine effect and vital change after topical application of phenylephrine 2.5% and tropicamide 0.5% three times for retinopathy of prematurity (ROP) examination in preterm infants.

Methods: Pupillary diameter, blood pressure, pulse rate, and oxygen saturation were monitored before, and after up to 24 hours 60 ROP screening examinations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 15, 2017
• Est. primary completion date: October 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 32 Weeks to 34 Weeks

Eligibility

Inclusion Criteria:

• Infants who were first ROP examinations

• infants born before 32 weeks.

Exclusion Criteria:

• Developmental ocular and/or systemic anomalies.

• Drug use that can affect vital values

• Unstable general condition

• Food intolerance

• Recurrent vomiting.

Related Conditions & MeSH terms

• Retinal Diseases
• Retinopathy of Prematurity

Intervention

Drug:
• Drug used in the examination of premature infants.
to investigate side effects of eye drops used

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bulent Ecevit University

References & Publications (24)

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Belda S, Pallás CR, De la Cruz J, Tejada P. Screening for retinopathy of prematurity: is it painful? Biol Neonate. 2004;86(3):195-200. Epub 2004 Jul 5. — View Citation

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Cohen AM, Cook N, Harris MC, Ying GS, Binenbaum G. The pain response to mydriatic eyedrops in preterm infants. J Perinatol. 2013 Jun;33(6):462-5. doi: 10.1038/jp.2012.149. Epub 2012 Dec 13. — View Citation

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Khoo BK, Koh A, Cheong P, Ho NK. Combination cyclopentolate and phenylephrine for mydriasis in premature infants with heavily pigmented irides. J Pediatr Ophthalmol Strabismus. 2000 Jan-Feb;37(1):15-20. — View Citation

Laws DE, Morton C, Weindling M, Clark D. Systemic effects of screening for retinopathy of prematurity. Br J Ophthalmol. 1996 May;80(5):425-8. — View Citation

Lees BJ, Cabal LA. Increased blood pressure following pupillary dilation with 2.5% phenylephrine hydrochloride in preterm infants. Pediatrics. 1981 Aug;68(2):231-4. — View Citation

Lim DL, Batilando M, Rajadurai VS. Transient paralytic ileus following the use of cyclopentolate-phenylephrine eye drops during screening for retinopathy of prematurity. J Paediatr Child Health. 2003 May-Jun;39(4):318-20. — View Citation

Lux AL, Degoumois A, Barjol A, Mouriaux F, Denion E. Combination of 5% phenylephrine and 0.5% tropicamide eyedrops for pupil dilation in neonates is twice as effective as 0.5% tropicamide eyedrops alone. Acta Ophthalmol. 2017 Mar;95(2):165-169. doi: 10.11 — View Citation

Mitchell A, Hall RW, Erickson SW, Yates C, Hendrickson H. Systemic Absorption of Cyclopentolate and Adverse Events After Retinopathy of Prematurity Exams. Curr Eye Res. 2016 Dec;41(12):1601-1607. Epub 2016 May 9. — View Citation

Mitchell AJ, Green A, Jeffs DA, Roberson PK. Physiologic effects of retinopathy of prematurity screening examinations. Adv Neonatal Care. 2011 Aug;11(4):291-7. doi: 10.1097/ANC.0b013e318225a332. — View Citation

Neffendorf JE, Mota PM, Xue K, Hildebrand GD. Efficacy and safety of phenylephrine 2.5% with cyclopentolate 0.5% for retinopathy of prematurity screening in 1246 eye examinations. Eur J Ophthalmol. 2015 May-Jun;25(3):249-53. doi: 10.5301/ejo.5000540. Epub — View Citation

Ogüt MS, Bozkurt N, Ozek E, Birgen H, Kazokoglú H, Ogüt M. Effects and side effects of mydriatic eyedrops in neonates. Eur J Ophthalmol. 1996 Apr-Jun;6(2):192-6. — View Citation

Patel AJ, Simon JW, Hodgetts DJ. Cycloplegic and mydriatic agents for routine ophthalmologic examination: a survey of pediatric ophthalmologists. J AAPOS. 2004 Jun;8(3):274-7. — View Citation

Rush R, Rush S, Nicolau J, Chapman K, Naqvi M. Systemic manifestations in response to mydriasis and physical examination during screening for retinopathy of prematurity. Retina. 2004 Apr;24(2):242-5. — View Citation

Sindel BD, Baker MD, Maisels MJ, Weinstein J. A comparison of the pupillary and cardiovascular effects of various mydriatic agents in preterm infants. J Pediatr Ophthalmol Strabismus. 1986 Nov-Dec;23(6):273-6. — View Citation

Spencer R. Long-term visual outcomes in extremely low-birth-weight children (an American Ophthalmological Society thesis). Trans Am Ophthalmol Soc. 2006;104:493-516. — View Citation

Thanathanee O, Ratanapakorn T, Morley MG, Yospaiboon Y. Lower conjunctival fornix packing for mydriasis in premature infants: a randomized trial. Clin Ophthalmol. 2012;6:253-6. doi: 10.2147/OPTH.S28714. Epub 2012 Feb 15. — View Citation

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean pupillary diameter	will be measured with a ruler after 60 minutes instillation of mydriatic	an average of 1 year