Comparison of Instillation and Packing in Mydriasis for Premature Infants

Phase 4

Completed

• Conditions: Preterm Infants
• Interventions: Drug: 1% tropicamide and 2.5% phenylephrine

• Registration Number: NCT00877175
• Lead Sponsor: Khon Kaen University

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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-04-06
• Study First Submitted QC: 2009-04-06
• Study First Posted: 2009-04-07
• Primary Completion: 2009-05
• Study Completion: 2009-06
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-07
• Last Update Posted: 2012-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	1% tropicamide and 2.5% phenylephrine	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.
1	1% tropicamide and 2.5% phenylephrine	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Srinagarind Hospital; 🇹🇭 Khon Kaen, Thailand