Microdrop Administration of Phenylephrine and Cyclopentolate Eye Drops in Neonates

This study aims to find out if low dose versus very low dose pupil dilating eye microdrops are effective in premature infants, and if the eye drops are associated with a low risk of harm.

Retinopathy of prematurity (ROP) is a major cause of blindness in babies born before 31 weeks gestational age or with a birth weight less than 1250 g. Because of the risk of permanent blindness, this group of premature infants have routine ROP eye examinations (ROPEE) involving administration of mydriatic (pupil dilating) eye drops.

Phenylephrine with cyclopentolate or tropicamide are the eye drop regimens used, but in neonatal units in Australia and New Zealand there is a wide variety of regimens in use. Regimens vary in concentration, drop volume and frequency of administration.

Mydriatics have been associated with clinically significant cardiovascular, respiratory and gastrointestinal adverse effects, and there is evidence low dose regimens are just as effective. Therefore, it is hoped this trial will provide guidance for clinical practice to help reduce the exposure of excessive doses that some premature infants are receiving.

Status: Recruitment completed

Sites: Wellington, Christchurch, Dunedin, Invercargill, Auckland

ANZCTR number: ACTRN12619000795190

Contact: lisa.kremer@otago.ac.nz