Purpose
To determine the symmetry on retinal image grading of fellow eyes for
retinopathy of prematurity (ROP) features (stage, zone and plus disease) and
severity, to provide the basis for the within subject comparison for ROP
trials.
Design
Secondary analyses of data from the Telemedicine Approaches to
Evaluating of Acute-Phase ROP (e-ROP) Study.
Subjects
Infants with birth weight less than 1251g.
Methods
Infants underwent serial retinal imaging sessions in both eyes by
certified imagers starting at 32-weeks postmenstrual age (PMA). Two trained
non-physician readers graded each eye independently for ROP features in a 5
retinal-image set from each session. Discrepancies were adjudicated by a
reading center supervisor. Readers were masked to all eye examination
results, previous gradings of both eyes, current grading of the fellow eye,
and demographic data.
Main Outcome Measures
The inter-eye agreement assessed using percent exact agreement and
weighted kappa (Kw) for stage, zone, plus,
referral-warranted ROP (RW-ROP, defined as presence of stage 3 or above,
plus disease, or zone I ROP), and severity of ROP.
Results
Among 3918 image sessions in 1235 infants, the percent agreement
(Kw) between paired eyes was
75.3% (0.65) for stage of ROP, 82.3% (0.68) for zone of ROP,
78.7% (0.51) for plus disease, 84.7% (0.56) for RW-ROP, and
72.7% (0.63) for severity of ROP. Similar inter-eye agreements were
found when considering ROP features at the first image session, at the last
image session, at any image session. Based on image evaluations from all
sessions, 412 (33.4%) infants had ROP stage 3 or above, 148
(12.0%) had zone I ROP, 70 (5.7%) had plus disease, and 419
(33.9%) had RW-ROP in one or both eyes; symmetrical findings were
present in 71.4% for ROP stage 3 or above, 56.8% for zone I
ROP, 50.0% for plus disease, and 73.7% for RW-ROP.
Conclusions
Masked image evaluations by trained readers showed good inter-eye
agreement in ROP characteristics, consistent with the high inter-eye
agreement in ROP from clinical examinations by ophthalmologists in other
studies. These data confirm that acute ROP is typically symmetrical and
supports within subject comparison in ROP trials.