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Objectives To describe adverse events (AEs) and noteworthy clinical or ocular findings associated with retinopathy of prematurity (ROP) evaluation procedures. Study design Descriptive analysis of pre-defined AEs and noteworthy findings reported in a prospective observational cohort study of infants <1251 g birth weight (BW) who had ROP study visits consisting of both binocular indirect ophthalmoscopy (BIO) and digital retinal imaging. We compared infant characteristics during ROP visits with and without AEs. We compared respiratory support, nutrition, and number of apnea, bradycardia, or hypoxia events 12 hours before and after ROP visits. Results 1,257 infants, mean BW 802 g, had 4,263 BIO and 4,048 imaging sessions (total 8,311 procedures). No serious AEs were related to ROP visits. Sixty-five AEs were reported among 61 infants for an AE rate of 4.9% infants (61/1257) or 0.8% total procedures (65/8311 BIO + imaging). Most AEs were due to apnea, bradycardia, and/or hypoxia (68%), tachycardia (16%), or emesis (8%). At ROP visit, infants with AEs, compared with those without, were more likely to be on mechanical ventilation (26% versus 12%, p=0.04) even after adjustment for weight and PMA. Noteworthy clinical findings were reported during 8% BIO and 15% imaging exams. Respiratory and nutrition support were not significantly different before and after ROP evaluations. Conclusions Retinal imaging by non-physicians combined with BIO was safe. Noteworthy clinical findings occurred during both procedures. Ventilator support was a risk factor for AEs. Monitoring rates of AEs and noteworthy findings are important to the safe implementation of ROP imaging protocols. Trial registration Clinicaltrials.gov: NCT01264276

To the Editors:Children with Down syndrome (DS) are commonly seen by pediatric ophthalmologists because signifi cant ocular conditions are associated with the disorder. 1 The presence of optic nerve anomalies has been noted in various small case series on children with DS. 2,3 We sought to determine the prevalence and character of optic nerve abnormalities among patients with DS in a large pediatric cohort and to ascertain whether patients with DS and optic nerve fi ndings suggestive of an intracranial process (nerve elevation or pallor) had corresponding central nervous system pathology.A retrospective review of the charts of all patients with DS (10-year study period) seen by the ophthalmology service at Boston Children's Hospital was performed to identify those with optic nerve anomalies. One hundred sixteen patients with DS and optic nerve abnormalities were identifi ed (116 of 806, 14% of patients with DS). The most frequently identifi ed abnormality was a myopic appearance and/or peripapillary atrophy of the optic nerve head. Other anomalies included peripapillary pigmentation, scleral crescent, optic nerve pallor, and non-myopic peripapillary atrophy (Figure 1).Seventeen patients had elevated optic nerve heads (17 of 806, 2%), eight of whom underwent neuroimaging. No imaged patient was found to have pathology compatible with optic nerve swelling. B-scan ultrasonography was performed on fi ve patients, either after neuroimaging or as a primary diagnostic measure. Optic nerve head drusen were found in all of these children. Four patients with DS in the cohort had pale optic nerves. Optic nerve head anomalies were not attributable to an undiagnosed intracranial lesion in any case.Among the optic nerve anomalies identifi ed in our cohort, we focused particularly on those that could be associated with a vision-threatening or life-threatening process: optic nerve head elevation and optic nerve pallor. In previous small case series, optic nerve head elevation was noted in 3% to 5% of patients with DS. [2][3][4] In this investigation, none of those with elevated or pale nerves had undiagnosed life or vision-threatening pathology either clinically or by neuroimaging. This is consistent with prior research on CNS lesions in the DS population because solid intracranial tumors appear to be extremely rare in these patients. 5Based on our fi ndings in this study, we recommend a systematic approach to evaluating children with DS who have elevated-appearing optic nerves. B-scan ultrasonography may be employed as a fi rstline diagnostic modality in these patients. It is inexpensive, non-invasive, and sensitive for optic disc drusen. A positive scan obviates the need for costly and invasive testing because drusen can be monitored ophthalmoscopically and with visual fi eld testing. In the case of a negative scan, further measures should be considered, including neurologic consultation, neuroimaging, and lumbar puncture. Patients who demonstrate nerve pallor of unknown etiology may prompt neuroimaging in addition to neurol...