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.