Comparison of Instillation and Packing in Mydriasis for Premature Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yosanan Yospaiboon, Khon Kaen University
ClinicalTrials.gov Identifier:
NCT00877175
First received: April 6, 2009
Last updated: March 7, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Preterm Infants
Drug: 1% tropicamide and 2.5% phenylephrine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Comparison of Conventional Instillation and Lower Conjunctival Fornix Packing in Mydriasis for Premature Infants

Resource links provided by NLM:


Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • The primary outcome measure was the horizontal pupil diameter measured with a ruler in millimeters [ Time Frame: 40 minutes after mydriatric drugs ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: March 2009
Study Completion Date: June 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   1 Month to 4 Months
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877175

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

Publications:
Responsible Party: Yosanan Yospaiboon, Professor, Khon Kaen University
ClinicalTrials.gov Identifier: NCT00877175     History of Changes
Other Study ID Numbers: I50221, HE480729
Study First Received: April 6, 2009
Last Updated: March 7, 2012
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research

Keywords provided by Khon Kaen University:
preterm infants
mydriasis
pupil dilation

Additional relevant MeSH terms:
Mydriasis
Pupil Disorders
Eye Diseases
Phenylephrine
Tropicamide
Oxymetazoline
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on October 19, 2014