TY - JOUR
T1 - Validity of the Red Reflex Exam in the Newborn Eye Screening Test Cohort
AU - Ludwig, Cassie A.
AU - Callaway, Natalia F.
AU - Blumenkranz, Mark S.
AU - Fredrick, Douglas R.
AU - Moshfeghi, Darius M.
N1 - Funding Information:
Originally submitted April 7, 2017. Revision received July 12, 2017. Accepted for publication August 2, 2017. The material under consideration was presented at the Association for Research in Vision and Ophthalmology in Denver on May 3, 2015. This study was funded by a grant for the Giannini Foundation with additional support for both Natalia F. Callaway and Cassie A. Ludwig from a TL1 Clinical Research Training Program of the Stanford Clinical and Translational Science Award to Spectrum (NIH TL1 TR 001084). The Research Electronic Data Capture (REDCap) database tool hosted by Stanford University is maintained by the Stanford Center for Clinical Informatics grant support (Stanford CTSA award number UL1 RR025744 from NIH/NCRR). The authors report no relevant financial disclosures. Dr. Moshfeghi did not participate in the editorial review of this manuscript. Editor’s Note: Clarity Medical Systems, the original manufacturer of the Ret-Cam III Imaging System mentioned in this study, has since been acquired by Natus Medical Incorporated. The authors are grateful for the help of Andrew Martin, PhD (Stanford Center for Clinical Informatics), who provided database design and management. Address correspondence to Darius M. Moshfeghi, MD, Professor of Ophthalmology, Byers Eye Institute, Horngren Family Vitreoretinal Center, Department of Ophthalmology, Stanford University School of Medicine, 2452 Watson Court, Room 2277, Palo Alto, CA 94303; email: [email protected]. doi: 10.3928/23258160-20180129-04
PY - 2018/2
Y1 - 2018/2
N2 - BACKGROUND AND OBJECTIVE: The validity of the red reflex exam has yet to be tested against new methods of wide-angle imaging that may improve early detection of neonatal ocular pathology. The authors aimed to determine the validity of the pediatrician’s red reflex exam using 130° wide-angle external and fundus digital imaging as a gold standard. PATIENTS AND METHODS: This was a prospective cohort study of 194 healthy, term newborns enrolled in the Newborn Eye Screening Test study at Lucile Packard Children’s Hospital from July 25, 2013, to July 25, 2014. Red reflex screening was performed by a pediatrician in the newborn nursery and wide-angle fundus digital imaging was performed by a neonatal intensive care unit-certified nurse. The main outcome measure was the validity of the pediatrician’s red reflex exam (unweighted kappa [κ] statistic, sensitivity, specificity). RESULTS: Compared to no subjects with abnormal red reflex exams reported in the pediatrician’s notes, 49 subjects demonstrated one or multiple ocular abnormalities on 130° wide-angle fundus imaging (κ = 0.00). The pediatrician’s red reflex exam had a sensitivity of 0.0% (95% CI, 0.0%-7.3%) and specificity of 100.0% (95% CI, 97.5%-100.0%) for the detection of ocular abnormalities. CONCLUSION: This study demonstrates the ability of wide-angle fundus imaging to detect fundus abnormalities not otherwise identified by standard newborn red reflex screening prior to hospital discharge.
AB - BACKGROUND AND OBJECTIVE: The validity of the red reflex exam has yet to be tested against new methods of wide-angle imaging that may improve early detection of neonatal ocular pathology. The authors aimed to determine the validity of the pediatrician’s red reflex exam using 130° wide-angle external and fundus digital imaging as a gold standard. PATIENTS AND METHODS: This was a prospective cohort study of 194 healthy, term newborns enrolled in the Newborn Eye Screening Test study at Lucile Packard Children’s Hospital from July 25, 2013, to July 25, 2014. Red reflex screening was performed by a pediatrician in the newborn nursery and wide-angle fundus digital imaging was performed by a neonatal intensive care unit-certified nurse. The main outcome measure was the validity of the pediatrician’s red reflex exam (unweighted kappa [κ] statistic, sensitivity, specificity). RESULTS: Compared to no subjects with abnormal red reflex exams reported in the pediatrician’s notes, 49 subjects demonstrated one or multiple ocular abnormalities on 130° wide-angle fundus imaging (κ = 0.00). The pediatrician’s red reflex exam had a sensitivity of 0.0% (95% CI, 0.0%-7.3%) and specificity of 100.0% (95% CI, 97.5%-100.0%) for the detection of ocular abnormalities. CONCLUSION: This study demonstrates the ability of wide-angle fundus imaging to detect fundus abnormalities not otherwise identified by standard newborn red reflex screening prior to hospital discharge.
UR - http://www.scopus.com/inward/record.url?scp=85042096085&partnerID=8YFLogxK
U2 - 10.3928/23258160-20180129-04
DO - 10.3928/23258160-20180129-04
M3 - Article
C2 - 29443359
AN - SCOPUS:85042096085
SN - 2325-8160
VL - 49
SP - 103
EP - 110
JO - Ophthalmic Surgery Lasers and Imaging Retina
JF - Ophthalmic Surgery Lasers and Imaging Retina
IS - 2
ER -