Purpose
In spite of standardized neonatal ophthalmic examinations, a cohort of children continues to have vision and eye disorders that go undetected. We utilized data collected in a prospective cohort study to detect the validity of the pediatric ophthalmic exam using RetCam III digital imaging as a gold standard. We hypothesized that the pediatric newborn ophthalmic exam has poor sensitivity for detecting ophthalmic abnormalities, which may lead to undetected vision disorders.
Methods
This study included 202 newborns screened in the Newborn Eye Screening Test (NEST) study conducted at Lucile Packard Children’s Hospital (LPCH). Pathology detected on imaging reviewed by a pediatric vitreoretinal specialist was compared with pathology reported in all pediatrician notes prior to newborn discharge. The primary outcome was the validity of the pediatric eye exam using RetCam III imaging as a gold standard as measured by sensitivity, specificity and Cohen’s unweighted kappa statistic. Secondary outcomes included frequency of exam maneuvers performed and frequency of all pathology detected in the cohort.
Results
This study demonstrates low sensitivity (12.9%) and positive agreement (8.5%) of the pediatric ophthalmic exam as compared to digital imaging of newborns (Tables 1 and 2). Compared to 20 subjects with abnormal ophthalmic findings reported in pediatrician notes, 70 subjects demonstrated one or multiple ophthalmic abnormalities on RetCam III imaging (κ = 0.05, CI: -0.06-0.16). Only 1/202 subjects demonstrated agreement on the type of abnormality reported by the pediatric ophthalmic exam and the RetCam III (conjunctival hemorrhage). External examination was the most common exam maneuver reported (99.5%) followed by the red reflex exam (96%), the pupillary exam (86.6%) and the extraocular motility and alignment exam (32.2%).
Conclusions
The pediatric newborn ophthalmic exam has poor sensitivity and positive agreement as compared to digital imaging for detecting ophthalmic abnormalities. Future studies will monitor the NEST cohort longitudinally to detect changes in vision that may be related to pathology detected with digital ophthalmic imaging.