Comparison of Instillation and Packing in Mydriasis for Premature Infants

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Preterm Infants

Intervention / Treatment
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* Drug: 1% tropicamide and 2.5% phenylephrine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 4 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* 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.<br>|
| Active Comparator: 2<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure was the horizontal pupil diameter measured with a ruler in millimeters |  | 40 minutes after mydriatric drugs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm infants, mydriasis, pupil dilation