Efficacy and Safety of Phenylephrine 2.5% with Cyclopentolate 0.5% for Retinopathy of Prematurity Screening in 1246 Eye Examinations

Purpose Retinopathy of prematurity (ROP) is a leading cause of visual loss in infancy that is largely preventable with careful screening. We report the safety and efficacy of the use of phenylephrine 2.5% and cyclopentolate 0.5% eyedrops instilled 3 times 5 minutes apart in ROP screening. Methods A total of 1246 ROP screening eye examinations were carried out by the same pediatric ophthalmologist between February 2011 and May 2013. Outcome measures were successful mydriasis (defined as achieving a full screening examination) and any intraprocedural systemic complications (defined as any respiratory, cardiac, or other clinical deterioration severe enough to result in screening abandonment). Results Of 1246 eyes, 1234 (98.8%) achieved successful dilation to enable complete screening. A fourth application was successful in the remaining 1.2%. No respiratory or cardiac arrest or any other intraprocedural event requiring cessation of screening was encountered during any of the examinations. No retinal bleeding or other intraocular complication occurred. Conclusions This is the largest cohort studying the effectiveness and safety of a mydriatic regimen for ROP screening. We have found the combination of phenylephrine 2.5% with cyclopentolate 0.5% to be efficacious and well-tolerated. The absence of any severe intraprocedural complications may be related to reduced indentation time and stress in the infant facilitated by effective pupil dilation.