Childhood ocular safety after postnatal exposure to topical dexamethasone during retinopathy of prematurity screening

PURPOSE: Dexamethasone eye drops are being introduced off-label to prevent progression of severe retinopathy of prematurity (ROP). We evaluated ophthalmologic outcomes in early childhood after postnatal topical dexamethasone exposure in pre-term infants at a standardized follow-up examination. METHODS: This prospective cross-sectional follow-up study included preterm infants born between 2019 and 2022 in the Västra Götaland region, Sweden, who received topical dexamethasone off-label during ROP screening. As a follow-up, a single standardized ophthalmological examination assessed visual acuity, refractive error, ocular motility, intraocular pressure (IOP) and structural ocular abnormalities. RESULTS: Twenty-four infants (median gestational age 25.0 weeks, range 22.6-27.7 weeks; 58% male) were examined at a median age of 2.9 years (range 1.1-5.0 years). Dexamethasone eye drops were initiated mainly for severe ROP at a median postmenstrual age of 35.1 weeks (range 32.0-52.0 weeks) and given for a median duration of 28 days (range 4-136 days). Median IOP was 18.9 mmHg (range 9.0-22.3 mmHg), and no child showed clinical signs of glaucoma. One child had a unilateral peripheral lens opacity without visual significance. No other ocular structural abnormalities were detected. Strabismus was detected in 2 (8%) of the children, and 3 (12%) had refractive errors. CONCLUSION: Preliminary data from extremely preterm infants exposed to off-label topical dexamethasone during ROP screening showed no clinically significant ocular adverse effects at standardized early childhood follow-up. Rates of strabismus and refractive errors were lower than expected. Larger studies with longer follow-up are needed to further assess ocular and systemic safety.