Abstract
Purpose :
A retinopathy of prematurity (ROP) activity scale was developed to provide a standardized ordinal approach to track disease progression and regression in clinical trials (Smith et al., 2018). We sought to validate the activity scale in two large, diverse cohorts.
Methods :
Secondary analysis of two multicenter cohort studies (one retrospective and one prospective) conducted at 45 hospitals in North America (G-ROP). Stage, zone and plus diagnoses of eyes were used to assign activity scores ranging from 0 to 22; and mild (0-7), moderate(8-12), and severe(13-22) classifications; following the paradigm in the original publication. Primary outcomes were proportions of eyes developing Type 1 ROP or treatment.
Results :
95,067 examinations of 22,899 eyes were studied. ROP was “mild” in 92.8%, moderate in 5.1%, and severe in 2.1% of examinations. Risk of Type 1 ROP/treatment increased with increasing initial-examination activity score for all but 3 of the 22 levels. Across all postmenstrual ages, “moderate”scores had higher risk of progression to Type 1/treatment than “mild”scores. At treatment, 79.4% of treated eyes had “severe”, 16.6% “moderate”, and 3.9% “mild” disease scores.
Conclusions :
This ROP activity scale was validated using patient data. The findings generally support the scale sequence and broad categorizations of severity, but the sequences of scale points for which risk of Type 1/treatment does not increase stepwise should be reconsidered.
This is a 2020 ARVO Annual Meeting abstract.