Comparison of Instillation and Packing in Mydriasis for Premature Infants

Preterm Infants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00877175
• Other study ID #: I50221
• Secondary ID: HE480729
• Status: Completed
• Phase: Phase 4
• First received: April 6, 2009
• Last updated: March 7, 2012
• Start date: March 2009
• Est. completion date: June 2009

Study information

• Verified date: March 2012
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Khon Kaen University Ethics Committee for Human Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 4 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Mydriasis
• Preterm Infants

Intervention

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.

Locations

Country	Name	City	State
Thailand	Srinagarind Hospital	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Thanathanee O, Ratanapakorn T, Morley MG, Yospaiboon Y. Lower conjunctival fornix packing for mydriasis in premature infants: a randomized trial. Clin Ophthalmol. 2012;6:253-6. doi: 10.2147/OPTH.S28714. Epub 2012 Feb 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure was the horizontal pupil diameter measured with a ruler in millimeters		40 minutes after mydriatric drugs	No