Comparison of Instillation and Packing in Mydriasis for Premature Infants

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00877175

Enrollment

Registered

2009-04-07

Start date

2009-03-31

Completion date

2009-06-30

Last updated

2012-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Infants

Keywords

preterm infants, mydriasis, pupil dilation

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.

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.

Interventions

DRUG1% 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Months to 4 Months

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

Design outcomes

Primary

Measure	Time frame
The primary outcome measure was the horizontal pupil diameter measured with a ruler in millimeters	40 minutes after mydriatric drugs

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026