None listed
Conditions
Brief summary
Phenylephrine and cyclopentolate are two medicines that are currently used at Dunedin Hospital during retinopathy of prematurity screening (eye checks). The two medicines are used to dilate the pupil so the retina can be viewed. Both of these medicines have been associated with harmful side effects such as necrotising enterocolitis, can cause reflux, feed intolerance, increase in blood pressure (which can increase the risk of intraventricular haemorrhage), increase in heart rate and there are case reports of seizures. One of the ways side effects can be reduced, is to reduce the amount of medication administered (i.e. reduce the dose). It is known from published papers that small doses of these two medicines are likely to be effective in dilating pupils. What is unknown is if even smaller doses are effective, and this is what this study will compare – standard eye drop doses to half the usual dose. The hope of the researchers, is that results from this study will suggest if using an even lower dose of phenylephrine and cyclopentolate will be effective in dilating neonatal pupils, with minimal side effects.
Interventions
Participants will be randomised to receive either a combination of;
1. One combination microdrop (7 microlitre) of both phenylephrine 1% and cyclopentolate 0.2% to both eyes. Participants will have one to three doses administered depending on pupil dilation.
2. One combination microdrop (7 microlitre) of both phenylephrine 0.5% and cyclopentolate 0.1% to both eyes. Participants will have one to two doses administered depending on pupil dilation. If a third dose is required, it will be one com
Participants will be randomised to receive either a combination of; 1. One combination microdrop (7 microlitre) of both phenylephrine 1% and cyclopentolate 0.2% to both eyes. Participants will have one to three doses administered depending on pupil dilation. 2. One combination microdrop (7 microlitre) of both phenylephrine 0.5% and cyclopentolate 0.1% to both eyes. Participants will have one to two doses administered depending on pupil dilation. If a third dose is required, it will be one combination microdrop (7 microlitre) of both phenylephrine 1% and cyclopentolate 0.2% To develop an eye colour chart to determine light iris vs dark iris.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
6 Weeks to 4 Months
Healthy volunteers
Yes
Inclusion criteria
All neonates that meet the Dunedin Hospital, Neonatal Intensive Care Unit (NICU) retinopathy of prematurity (ROP) screening criteria. All infants who require pupil dilation for red reflex testing.
Exclusion criteria
Any neonate with ROP greater than stage 2. Any neonate with an ocular medical condition. If the staff member who administered the eye drop was unsure if the microdrop reached the eye, then the neonate will be excluded from the trial, in accordance with the per-protocol study design. Any neonate whom phenylephrine and/or cyclopentolate is contraindicated.
Outcome results
None listed