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Comparison of Instillation and Packing in Mydriasis for Premature Infants

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ClinicalTrials.gov Identifier: NCT00877175
Recruitment Status : Completed
First Posted : April 7, 2009
Last Update Posted : March 9, 2012
Sponsor:
Information provided by (Responsible Party):
Yosanan Yospaiboon, Khon Kaen University

Brief Summary:
The purpose of this study is to compare the mydriatic effect of 2.5% phenylephrine and 1% tropicamide by conventional instillation and lower conjunctival fornix packing in premature infants.

Condition or disease Intervention/treatment Phase
Preterm Infants Drug: 1% tropicamide and 2.5% phenylephrine Phase 4

Detailed Description:
Adequate pupil dilatation was needed for screening and treatment of retinopathy of prematurity (ROP) in premature infants.In general clinical practice, mydriatic drugs were instilled many times until the pupil reached the maximum size. However, poor mydriasis were found in many eyes despite maximum instillation was used. From the clinical observation, we found the packing of mydriatic drugs in lower conjunctival fornix was much more effective to dilate the pupil than instillation in some patients. The purpose of this study was to compare the mydriatic effect of 2.5% phenylephrine and 1% tropicamide by conventional instillation and lower conjunctival fornix packing in premature infants.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Comparison of Conventional Instillation and Lower Conjunctival Fornix Packing in Mydriasis for Premature Infants
Study Start Date : March 2009
Actual Primary Completion Date : May 2009
Actual Study Completion Date : June 2009


Arm Intervention/treatment
Experimental: 1
Lower conjunctival fornix packing arm. For the eyes receiving lower conjunctival fornix packing (study group), one small piece of the cotton wool soaked with one drop of 2.5% phenylephrine and one drop of 1% tropicamide was packed in the lower conjunctival fornix.
Drug: 1% tropicamide and 2.5% phenylephrine
For the eyes receiving lower conjunctival fornix packing (study group), one small piece of the cotton wool soaked with one drop of 2.5% phenylephrine and one drop of 1% tropicamide was packed in the lower conjunctival fornix. For the eyes receiving the instillation (control group), 2.5% phenylephrine and 1% tropicamide were alternately instilled every 5 minutes for two doses each.

Active Comparator: 2
Conventional instillation arm. For the eyes receiving the instillation (control group), 2.5% phenylephrine and 1% tropicamide were alternately instilled every 5 minutes for two doses each.
Drug: 1% tropicamide and 2.5% phenylephrine
For the eyes receiving lower conjunctival fornix packing (study group), one small piece of the cotton wool soaked with one drop of 2.5% phenylephrine and one drop of 1% tropicamide was packed in the lower conjunctival fornix. For the eyes receiving the instillation (control group), 2.5% phenylephrine and 1% tropicamide were alternately instilled every 5 minutes for two doses each.




Primary Outcome Measures :
  1. The primary outcome measure was the horizontal pupil diameter measured with a ruler in millimeters [ Time Frame: 40 minutes after mydriatric drugs ]


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Ages Eligible for Study:   1 Month to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • gestational age of less than 32 weeks and/or the birth weight of less than 1,500 grams
  • stable clinical course

Exclusion Criteria:

  • history of intraocular surgery or laser treatment
  • previous eyedrop instillation that might affect the pupil size
  • severe underlying disease or unstable clinical course that mydriatic drugs or the examination could aggravate their conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00877175


Locations
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Thailand
Srinagarind Hospital
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University
Investigators
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Principal Investigator: Yosanan Yospaiboon, M.D. Department of Ophthalmology, Faculty of Medicine, Khon Kaen University

Publications of Results:
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Responsible Party: Yosanan Yospaiboon, Professor, Khon Kaen University
ClinicalTrials.gov Identifier: NCT00877175     History of Changes
Other Study ID Numbers: I50221
HE480729
First Posted: April 7, 2009    Key Record Dates
Last Update Posted: March 9, 2012
Last Verified: March 2012
Keywords provided by Yosanan Yospaiboon, Khon Kaen University:
preterm infants
mydriasis
pupil dilation
Additional relevant MeSH terms:
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Mydriasis
Pupil Disorders
Eye Diseases
Phenylephrine
Oxymetazoline
Tropicamide
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents