Retinopathy of Prematurity (ROP) Clinical Trial
Official title:
A Randomized Controlled Trial to Determine the Lowest Effective Dose for Adequate Mydriasis in Premature Infants
The purpose of this study is to compare the dilating effect of 0, 1, 2 or 3 drops of mydriatic (pupil dilating) in premature infants undergoing routine retinal (eye) screening exams for Retinopathy of Prematurity (ROP).
Premature infants need to have eye exams starting at about 4 weeks of age and continuing
until their retinas (membrane at the back of the eye which collects and transfers light) is
fully grown. These exams are done to see if they have developed ROP, a disease which can
lead to blindness if not treated.
The ophthalmologist (eye doctor) looks through the enlarged pupil (opening at the front of
the eye) to see the retina. The drug that is used to dilate the pupil, Cyclomydril, has been
shown to have side effects in premature infants. No literature has shown what the optimal
dose is for premature babies. Nursery policy is to give 3 drops of Cyclomydril in each eye,
at 5 minute intervals, 45-60 minutes before a scheduled eye exam. We sought to reduce the
dose without delaying the exam for an under-sized pupil.
In the study, each infant is randomized at the time of the exam to receive either 0, 1 or 2
drops of Cyclomydril in the left eye and 3 drops in the right eye to serve as their own
control. The zero-drop group was created to test the contralateral (opposite eye) effect of
3 drops in the right eye. Pupil dilation size is measured using the Colvard pupillometer by
a Pediatric Ophthalmologist examiner (G.V.V.) who was not masked to study group assignment.
Measures of pupil size are done at baseline (before any drops given), 45, 90 and 120 minutes
after the first drop was given. ROP screening exam is done at the first opportunity to
visualize the posterior and peripheral retina.
Additional drops are given at 120 minutes if the observer is unable to complete the exam
prior to that point.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Screening
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