NCT00877175

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Khon Kaen University · Academic / Other
• Sex: All
• Age: 1 Month – 4 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Preterm Infants

Interventions

Type	Name	Description
DRUG	1% 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.

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-05-01
• Completion: 2009-06-01
• First posted: 2009-04-07
• Last updated: 2012-03-09

Locations

1 site across 1 country: Thailand