Comparison of Instillation and Packing in Mydriasis for Premature Infants

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.

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Key information

Conditions

Preterm Infants Eye Diseases Mydriasis Pupil Disorders

Age range

1 month–4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Srinagarind Hospital

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

Time frame: 40 minutes after mydriatric drugs

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Official study title

Comparison of Conventional Instillation and Lower Conjunctival Fornix Packing in Mydriasis for Premature Infants

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Apr 7, 2009
Registry last updated: Mar 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed