Comparison of Instillation and Packing in Mydriasis for Premature Infants

Khon Kaen University

Status and phase: Completed; Phase 4

Conditions: Preterm Infants

Treatments: Drug: 1% tropicamide and 2.5% phenylephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT00877175

I50221

HE480729

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 1 to 4 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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25 participants in 2 patient groups

1

Experimental group

Description:

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.

Treatment:

Drug: 1% tropicamide and 2.5% phenylephrine

2

Active Comparator group

Description:

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.

Treatment:

Drug: 1% tropicamide and 2.5% phenylephrine