Abstract
Purpose :
To examine the incidence of asymmetrical disease in infants with moderate to severe retinopathy of prematurity (ROP).
Methods :
228 infants were recruited in this multi-center, prospective, cohort study from 7 centers. Bilateral wide-angle retinal images were captured after routine exam, and a consensus reference standard diagnosis (RSD) was determined from the color fundus images by three experienced readers in combination with the clinical diagnosis. For each exam session, the RSD (presence of ROP, zone, stage, plus disease, disease category) was compared between eyes. Attention was paid to identifying the findings in the fellow eye of eyes with moderate to severe ROP, defined as type-2 disease (zone I, stage 1 or 2 ROP without plus disease or as zone II, stage 3 ROP without plus disease) or worse.
Results :
607 exam sessions from 228 infants (mean 2.66 sessions per infant, range 1-13) were included. Of 72 sessions with a RSD of stage 3 or worse, the fellow eye had a diagnosis of stage 3 or worse in 46 sessions (64%) (Fig 1B). Of 78 sessions with a RSD of Zone I, the fellow eye had a diagnosis of Zone I in 70 sessions (90%) (Fig 1D). Of 25 sessions with a RSD of plus disease, the fellow eye had a diagnosis of plus disease in 12 sessions (48%) (Fig 1E). Of 149 sessions with a RSD of type-2 or pre-plus, the fellow eye had a diagnosis of type-2 or pre-plus in 95 sessions (64%) and treatment-requiring ROP in 12 sessions (8%) (Fig 1C). Of 48 sessions with a RSD of treatment-requiring ROP, the fellow eye had a diagnosis of treatment-requiring ROP in 31 sessions (65%), type-2 or pre-plus in 12 sessions (25%), mild ROP in 4 sessions (8%), and no ROP in 1 session (2%) (Fig 1A).
Conclusions :
We report concordance rates of clinically significant ROP diagnoses in moderate to severe ROP, which was highest for zone I disease and lowest for plus disease. The incidence of bilateral treatment-requiring ROP was lower in our cohort compared to previously published rates in the Cryotherapy for ROP and Early Treatment for ROP trials. This data may be relevant to the planning of clinical trials and may furnish guidelines for study design. Our findings may also have implications in screening and management of ROP, especially if we continue to evaluate our algorithm for treatment-requiring ROP.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.