Purpose
ROP is extremely important from clinical and medicolegal perspectives because it places infants at risk for lifelong blindness. Based on findings from the multicenter studies, a consensus published policy statement recommends treatment for Type 1 or worse disease, defined as zone I, stage 3; zone I, any stage with plus disease; or zone II, stage 2 or 3, with plus disease. However, it is our anecdotal experience that experts occasionally recommend treatment for disease milder than Type 1, because of concerns about specific disease features. The purpose of this study is to characterize the frequency and nature of this practice.
Methods
A multicenter database was generated from infants screened for ROP at one of 6 major ROP centers in the United States, whose parents consented for participation. The database was reviewed to identify all infants treated for ROP at those centers. Among those, eyes treated for a clinical exam milder than Type 1 disease were identified. Clinical records of these infants were reviewed to confirm the diagnosis prior to treatment and to determine the specific indication for treatment.
Results
Among 722 infants (4795 eye exams in 1444 eyes) in the study database, 137 eyes (9.5%) of 70 infants (9.7%) were treated for ROP with laser or intravitreal antiVEGF agents. Among these 137 treated eyes, 13 eyes (9.5%) of 9 infants (12.9%) were treated despite a clinical diagnosis milder than Type 1 ROP (Table 1). Indications for treatment were temporal vessel straightening (6 eyes, 46.2%), Type 2 ROP with vitreous hemorrhage (3 eyes, 23.1%), mild ROP with Type 1 ROP in the fellow eye (2 eyes, 15.4%), stage 3 ROP with vitreoretinal traction concerning for progression to stage 4A ROP (2 eyes, 15.4%), progressive stage 3 at an advanced postmenstrual age (1 eye, 7.7%), and persistent ROP at 12 months of age in a patient with stage 5 ROP in the fellow eye (1 eye, 7.7%).
Conclusions
Experts in this study often recommended ROP treatment in eyes with disease milder than Type 1. This finding has important implications in ROP for clinical and medicolegal reasons, and more broadly regarding application of individual clinical judgment in scenarios that are not precisely covered by evidence-based treatment guidelines.