Comparison of Instillation and Packing in Mydriasis for Premature Infants

NCT00877175 | Completed Phase 4 DMC

• 2 other identifiers: I50221HE480729
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Infants

Keywords

preterm infants; mydriasis; pupil dilation

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure was the horizontal pupil diameter measured with a ruler in millimeters

  40 minutes after mydriatric drugs

Study Arms (2)

1

EXPERIMENTAL

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

2

ACTIVE COMPARATOR

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

Interventions

1% tropicamide and 2.5% phenylephrine DRUG

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.

1; 2

Eligibility Criteria

• Age: 1 Month - 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Srinagarind Hospital

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

Location

Related Publications (1)

• 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: 22368443 RESULT

MeSH Terms

Conditions

Mydriasis

Interventions

Tropicamide; Phenylephrine

Condition Hierarchy (Ancestors)

Pupil Disorders; Eye Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Yosanan Yospaiboon, M.D.

  Department of Ophthalmology, Faculty of Medicine, Khon Kaen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 6, 2009
• First Posted: April 7, 2009
• Study Start: March 1, 2009
• Primary Completion: May 1, 2009
• Study Completion: June 1, 2009
• Last Updated: March 9, 2012

Record last verified: 2012-03

Locations

TH (1)