Systematic review of mydriatics used for screening of retinopathy in premature infants

Abstract

Introduction: Routine retinopathy of prematurity eye examinations are an important part of neonatal care, and mydriatic medicines are essential in dilating the pupil for the eye examination. There are concerns about the level of evidence for efficacy and safety of these mydriatic medicines.

Objective: This review evaluates both efficacy and safety evidence of mydriatics used during the retinopathy of prematurity eye examination.

Method: Systematic literature review.

Results: There is limited evidence guiding clinical practice for safety and efficacy of mydriatics. The majority of publications are underpowered and with an unclear to high level of bias. There are a wide variety of mydriatic regimens evaluated for efficacy and safety, and multiple regimens are associated with case reports.

Conclusions: Current international guideline seems unnecessarily high, especially when the reviewed literature suggest that lower doses are effective, albiet from underpowered studies. The lowest effective combination regimen appears to be phenylephrine 1% and cyclopentolate 0.2% (1 drop). Microdrop administration of this regimen would further increase the safety profile, however, efficacy needs to be assessed.

Keywords: cyclopentolate; mydriatic; neonate; phenylephrine; retinopathy of prematurity; tropicamide.

Figure 1

Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram.

Figure 2

Cochrane tool risk of bias summary for randomised controlled trial (RCT) or quazi-RCT studies. Review authors' judgements about each risk of bias item for each included study. Key: ‘–’ indicates high risk of bias; ‘?’ indicates unclear risk of bias; ‘+’ indicates low risk of bias.

Figure 3

Pupil dilation results (mean and 95% CI) for treatment arms in RCTs, including quasi-RCT and cross-over RCT. The dotted line is the estimated pupil dilation (5 mm) that is required for an ophthalmologist to perform a successful retinopathy of prematurity eye examinations. C, cyclopentolate; d, drop; micro, microdrop; P, phenylephrine; RCT, randomised controlled trial; T, tropicamide.