Refractive, Visual and Retinal Outcomes after Intravitreal Ranibizumab Monotherapy for Retinopathy of Prematurity

Abstract

Background: Intravitreal ranibizumab (IVR) is increasingly used as an off-label treatment for retinopathy of prematurity (ROP). The most clinically used dose is 0.25 mg; however, its late outcomes are rarely reported. This study compares the late refractive, visual, and retinal outcomes in children with type 1 ROP treated with 0.25 mg IVR to those with type 2 ROP that regressed spontaneously. Methods: This retrospective study included 48 children (96 eyes) with ROP history. Birth history data, spherical equivalent (SE) of cycloplegic refraction, and the prevalence of visual and retinal anomalies were compared between type 1 (68 eyes) and type 2 ROP (28 eyes). Results: At a mean age of 3.47 years, children with type 1 ROP had significantly lower mean SE (+0.17D ± 3.60) than children with type 2 ROP (+1.99D ± 2.80) (P = 0.02). SE was significantly affected by repeated injections of IVR, leading to a reduction of SE and myopic shift. Risk factors of high myopia (SE ≤-5 diopters) include the presence of respiratory distress syndrome (RDS) (P = 0.01), advanced maternal age (P=0.02), in vitro fertilization (IVF) (P = 0.02), ROP type 1 (P = 0.01) ROP in zone 1 (P = 0.01) and repeated IVR treatment (P= 0.01). No significant difference was found between ROP types in the prevalence of hyperopia, myopia or emmetropia. The prevalence of visual anomalies (strabismus, fixation anomalies, nystagmus, amblyopia, and extraocular imbalances) and retinal anomalies (anomalies of the retinal surface, vasculature, and optic disc) were not significantly different between the groups. Conclusion: IVR monotherapy with 0.25 mg for ROP resulted in the myopic shift. Repeated IVR treatment increases the risk of high myopia. High myopia is also significantly associated with RDS, IVF, advanced maternal age, type 1 ROP, and ROP in zone 1. No association was found between IVR and visual or retinal anomalies.