A Phase 4 interventional study of 1% tropicamide and 2.5% phenylephrine in Preterm Infants, sponsored by Khon Kaen University. Completed at 1 site in Thailand. Open to participants aged 1 Month to 4 Months. Per ClinicalTrials.gov, last updated 2012-03-09.
Sponsored by Khon Kaen University · Phase 4, Interventional, and Diagnostic
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.
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.
37 studies on the registry are indexed under Mydriasis; 4 are open to participants now.
This study's enrollment of 25 is below the median of 61 across 35 interventional studies indexed under Mydriasis.
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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.
Drug: 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.
Drug: 1% tropicamide and 2.5% phenylephrine
Drug pages: Tropicamide · 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.
The primary outcome measure was the horizontal pupil diameter measured with a ruler in millimeters
Time frame: 40 minutes after mydriatric drugs
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Tropicamide · Phenylephrine