Comparison of Instillation and Packing in Mydriasis for Premature Infants

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00877175
• Date of registration: 06/04/2009
• Prospective Registration: No
• Primary sponsor: Khon Kaen University
• Public title: Comparison of Instillation and Packing in Mydriasis for Premature Infants
• Scientific title: Comparison of Conventional Instillation and Lower Conjunctival Fornix Packing in Mydriasis for Premature Infants
• Date of first enrolment: March 2009
• Target sample size: 25
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00877175
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
• Phase: Phase 4

Countries of recruitment

Thailand

Contacts

• Name: Yosanan Yospaiboon, M.D.
• Affiliation: Department of Ophthalmology, Faculty of Medicine, Khon Kaen University

Key inclusion & exclusion criteria

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



Age minimum: 1 Month
Age maximum: 4 Months
Gender: Both

Health Condition(s) or Problem(s) studied

Preterm Infants

Intervention(s)

Drug: 1% tropicamide and 2.5% phenylephrine

Primary Outcome(s)

The primary outcome measure was the horizontal pupil diameter measured with a ruler in millimeters [Time Frame: 40 minutes after mydriatric drugs]

Secondary ID(s)

HE480729

I50221

Source(s) of Monetary Support

Please refer to primary and secondary sponsors