NCT03448640

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

1.8 years

First QC Date

February 15, 2018

Last Update Submit

February 27, 2018

Conditions

Retinopathy of Prematurity

Outcome Measures

Primary Outcomes (1)

  • The mean pupillary diameter

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

    an average of 1 year

Interventions

Drug used in the examination of premature infants.DRUG

to investigate side effects of eye drops used

Also known as: Tropicamide and mydfline used

Eligibility Criteria

Age32 Weeks - 34 Weeks
Sexall(Gender-based eligibility)
Gender Eligibility Detailsneonatal
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

tertiary health center in the west Black Sea region

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (25)

  • 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.

    PMID: 17471358BACKGROUND

  • 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.

    PMID: 3454368BACKGROUND

  • 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.

    PMID: 4014388BACKGROUND

  • 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.

    PMID: 12755944BACKGROUND

  • 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.

    PMID: 10969255BACKGROUND

  • 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.

    PMID: 1982760BACKGROUND

  • 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.

    PMID: 22368443BACKGROUND

  • 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.

    PMID: 23238569BACKGROUND

  • Ballabh P. Intraventricular hemorrhage in premature infants: mechanism of disease. Pediatr Res. 2010 Jan;67(1):1-8. doi: 10.1203/PDR.0b013e3181c1b176.

    PMID: 19816235BACKGROUND

  • 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.

    PMID: 18280404BACKGROUND

  • 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.

    PMID: 8695564RESULT

  • 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.

    PMID: 7267230RESULT

  • 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.

    PMID: 6546977RESULT

  • 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.

    PMID: 20835704RESULT

  • 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.

    PMID: 10714690RESULT

  • 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.

    PMID: 27519933RESULT

  • 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.

    PMID: 8823596RESULT

  • 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.

    PMID: 22123352RESULT

  • 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.

    PMID: 15226730RESULT

  • 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.

    PMID: 15097885RESULT

  • 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.

    PMID: 25449644RESULT

  • 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.

    PMID: 27159349RESULT

  • Anand KJ. Clinical importance of pain and stress in preterm neonates. Biol Neonate. 1998;73(1):1-9. doi: 10.1159/000013953.

    PMID: 9458936RESULT

  • 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.

    PMID: 15240989RESULT

  • 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.

    PMID: 31690284DERIVED

MeSH Terms

Conditions

Retinopathy of Prematurity

Interventions

Tropicamide

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asociate Pofessor Atilla Alpay

Study Record Dates

First Submitted

February 15, 2018

First Posted

February 28, 2018

Study Start

January 15, 2016

Primary Completion

October 15, 2017

Study Completion

December 15, 2017

Last Updated

February 28, 2018

Record last verified: 2018-02