Nine-year ocular developmental outcomes after ranibizumab or laser treatment for zone II retinopathy of prematurity: follow-up of a randomized trial cohort.

UNLABELLED: The purpose of this study is to describe 9-year ocular developmental outcomes in children previously randomized to intravitreal ranibizumab (IVR) or laser photocoagulation (LP) for zone II treatment-requiring retinopathy of prematurity (ROP). In this follow-up of a single-center randomized trial, infants with stage 2 or 3 ROP with plus disease in zone II were randomized in 2014 to bilateral LP (n = 25) or IVR (n = 25). At school age, 29 children (10 LP, 19 IVR) underwent assessment of best-corrected visual acuity, cycloplegic refraction, ocular biometry, anterior segment parameters, spectral-domain optical coherence tomography, optical coherence tomography angiography, and full-field electroretinography. Eye-level comparisons used generalized estimating equations. Mean spherical equivalent did not differ significantly between LP and IVR groups (- 1.22 vs. - 1.90 D; mean difference 0.68 D, 95% CI - 2.26 to 3.62; p = 0.65), nor did best-corrected visual acuity (0.15 vs. 0.21 logMAR; mean difference - 0.07, 95% CI - 0.27 to 0.13; p = 0.51). Compared with the LP group, the IVR group showed thinner lens thickness (3.52 vs. 3.75 mm, p < 0.001), steeper minimum keratometry (43.8 vs. 42.6 D, p = 0.048), and thinner central internal limiting membrane-retinal pigment epithelium thickness (249.2 vs. 286.9 μm, p = 0.005). Selected electroretinography abnormalities also differed between groups.

CONCLUSION: In this small 9-year follow-up cohort with differential loss to follow-up, visual acuity and refractive outcomes were broadly similar after IVR and LP, while selected ocular structural and electrophysiological differences were observed. These preliminary exploratory findings should be interpreted cautiously and do not provide sufficient evidence to recommend one treatment approach over the other on the basis of long-term ocular outcomes alone.

WHAT IS KNOWN: • Laser photocoagulation and intravitreal anti-vascular endothelial growth factor therapy are established treatments for severe retinopathy of prematurity. • Long-term ocular developmental and functional outcomes after anti-vascular endothelial growth factor treatment remain incompletely defined, particularly beyond early childhood.

WHAT IS NEW: • This follow-up of a randomized trial cohort provides 9-year multimodal ocular outcome data in children treated with ranibizumab or laser for zone II retinopathy of prematurity. • Visual acuity and refractive outcomes were broadly similar between treatment groups, while selected anterior segment, retinal structural, and electroretinography differences were observed and should be interpreted as exploratory.