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Retinopathy of PrematurityNCT03448640

Efficacy of Mydriatic Drops in Premature Infants

An observational study of Retinopathy of Prematurity, run by Bulent Ecevit University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 32 to 34 weeks
Conditions the study is for
Retinopathy of Prematurity
What is being tested?
Drug used in the examination of premature infants.
How many people
60 participants
Where
No sites listed yet
Study dates
15 Jan 2016to 15 Dec 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 32 to 34 weeks
  • All sexes
  • No healthy volunteers
  • Child

Study population: tertiary health center in the west Black Sea region

Who may be able to join

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

Who cannot join

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

About this study

Official title: Efficiency and Safety of Phenylephrine and Tropicamide Used in Premature Retinopathy

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.

Being tested
Drug used in the examination of premature infants.
Medical subject headings
Retinopathy of Prematurity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Drug used in the examination of premature infants.Drug

    Also called Tropicamide and mydfline used

    to investigate side effects of eye drops used

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The mean pupillary diameter

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

    Measured: an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2018
  2. Study start15 Jan 2016
  3. Primary completion15 Oct 2017
  4. Study completion15 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03448640
Sponsor's protocol ID
BulentEU
Status last verified
Feb 2018
First submitted
15 Feb 2018
Last updated
28 Feb 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

An observational study of Retinopathy of Prematurity, run by Bulent Ecevit University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The mean pupillary diameter (time frame: an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03448640, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.

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