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CompletedNCT03448640Updated Feb 28, 2018

Efficacy of Mydriatic Drops in Premature Infants

An observational study in Retinopathy of Prematurity, sponsored by Bulent Ecevit University. Completed. Open to participants aged 32 Weeks to 34 Weeks. Per ClinicalTrials.gov, last updated 2018-02-28.

Sponsored by Bulent Ecevit University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
32 Weeks to 34 Weeks
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Retinopathy of Prematurity
03

Who can participate

Ages eligible
32 Weeks to 34 Weeks
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

tertiary health center in the west Black Sea region

Inclusion criteria

  • Infants who were first ROP examinations
  • infants born before 32 weeks.

Exclusion criteria

Exclusion Criteria:

  • Developmental ocular and/or systemic anomalies.
  • Drug use that can affect vital values
  • Unstable general condition
  • Food intolerance
  • Recurrent vomiting.
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Interventions

  • DrugDrug used in the examination of premature infants.

    to investigate side effects of eye drops used

    Also known as: Tropicamide and mydfline used

05

What researchers measure

Primary outcomes

  1. The mean pupillary diameter

    will be measured with a ruler after 60 minutes instillation of mydriatic

    Time frame: an average of 1 year

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Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 17471358 ↗
  • 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. doi: 10.3928/0191-3913-19861101-04. PubMed 3454368 ↗
  • Clarke WN, Hodges E, Noel LP, Roberts D, Coneys M. The oculocardiac reflex during ophthalmoscopy in premature infants. Am J Ophthalmol. 1985 Jun 15;99(6):649-51. doi: 10.1016/s0002-9394(14)76029-5. PubMed 4014388 ↗
  • 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. doi: 10.1046/j.1440-1754.2003.00144.x. PubMed 12755944 ↗
  • Bonthala S, Sparks JW, Musgrove KH, Berseth CL. Mydriatics slow gastric emptying in preterm infants. J Pediatr. 2000 Sep;137(3):327-30. doi: 10.1067/mpd.2000.107842. PubMed 10969255 ↗
  • Chien DS, Homsy JJ, Gluchowski C, Tang-Liu DD. Corneal and conjunctival/scleral penetration of p-aminoclonidine, AGN 190342, and clonidine in rabbit eyes. Curr Eye Res. 1990 Nov;9(11):1051-9. doi: 10.3109/02713689008997579. PubMed 1982760 ↗
  • 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. PubMed 22368443 ↗
  • 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. PubMed 23238569 ↗
  • Ballabh P. Intraventricular hemorrhage in premature infants: mechanism of disease. Pediatr Res. 2010 Jan;67(1):1-8. doi: 10.1203/PDR.0b013e3181c1b176. PubMed 19816235 ↗
  • Wilkinson AR, Haines L, Head K, Fielder AR. UK retinopathy of prematurity guideline. Early Hum Dev. 2008 Feb;84(2):71-4. doi: 10.1016/j.earlhumdev.2007.12.004. No abstract available. PubMed 18280404 ↗
  • 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. doi: 10.1136/bjo.80.5.425. PubMed 8695564 ↗
  • 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. PubMed 7267230 ↗
  • Isenberg S, Everett S, Parelhoff E. A comparison of mydriatic eyedrops in low-weight infants. Ophthalmology. 1984 Mar;91(3):278-9. doi: 10.1016/s0161-6420(84)34303-2. PubMed 6546977 ↗
  • Alpay A, Ermis B, Ugurbas SC, Battal F, Sagdik HM. The local vasoconstriction of infant's skin following instillation of mydriatic eye drops. Eur J Clin Pharmacol. 2010 Nov;66(11):1161-4. doi: 10.1007/s00228-010-0890-6. Epub 2010 Sep 11. PubMed 20835704 ↗
  • 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. doi: 10.3928/0191-3913-20000101-05. PubMed 10714690 ↗
  • 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: 10.1111/aos.13175. Epub 2016 Aug 13. PubMed 27519933 ↗
  • Ogut MS, Bozkurt N, Ozek E, Birgen H, Kazokoglu H, Ogut M. Effects and side effects of mydriatic eyedrops in neonates. Eur J Ophthalmol. 1996 Apr-Jun;6(2):192-6. doi: 10.1177/112067219600600218. PubMed 8823596 ↗
  • 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. PubMed 22123352 ↗
  • 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. doi: 10.1016/j.jaapos.2004.01.004. PubMed 15226730 ↗
  • 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. doi: 10.1097/00006982-200404000-00009. PubMed 15097885 ↗
  • 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 2014 Nov 14. PubMed 25449644 ↗
  • Mitchell A, Hall RW, Erickson SW, Yates C, Lowery S, Hendrickson H. Systemic Absorption of Cyclopentolate and Adverse Events After Retinopathy of Prematurity Exams. Curr Eye Res. 2016 Dec;41(12):1601-1607. doi: 10.3109/02713683.2015.1136419. Epub 2016 May 9. Erratum In: Curr Eye Res. 2018 Aug;43(8):1065. doi: 10.1080/02713683.2018.1489450. PubMed 27159349 ↗
  • Anand KJ. Clinical importance of pain and stress in preterm neonates. Biol Neonate. 1998;73(1):1-9. doi: 10.1159/000013953. PubMed 9458936 ↗
  • Belda S, Pallas CR, De la Cruz J, Tejada P. Screening for retinopathy of prematurity: is it painful? Biol Neonate. 2004;86(3):195-200. doi: 10.1159/000079542. Epub 2004 Jul 5. PubMed 15240989 ↗
  • Alpay A, Canturk Ugurbas S, Aydemir C. Efficiency and safety of phenylephrine and tropicamide used in premature retinopathy: a prospective observational study. BMC Pediatr. 2019 Nov 6;19(1):415. doi: 10.1186/s12887-019-1757-3. PubMed 31690284 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03448640
Lead sponsor
Bulent Ecevit University
Responsible party
Atilla Alpay (Asociate Pofessor Atilla Alpay, Bulent Ecevit University) — Principal investigator
First posted
Feb 28, 2018
Start date
Jan 15, 2016
Primary completion
Oct 15, 2017
Completion
Dec 15, 2017
Last update
Feb 28, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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