Dexamethasone Eye Drops to Prevent Treatment-Requiring Retinopathy of Prematurity: The DROPROP Randomized Clinical Trial.
Ann Hellström, Mariya Petrishka-Lozenska, Ulrika Sjöbom et al.
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In 30 seconds
The DROPROP double-masked, multicentre randomised clinical trial tested whether topical dexamethasone could prevent progression to treatment-requiring type 1 retinopathy of prematurity (ROP) in preterm infants born before 30 weeks’ gestational age with severe ROP. Among 100 infants, type 1 ROP developed in 10 of 50 (20.0%) assigned dexamethasone and 19 of 50 (38.0%) assigned placebo; the adjusted odds ratio was 0.44 (95% CI, 0.17-1.12; P = .08). The difference was not statistically significant. No clinically significant differences in adverse events were observed between groups.
Key findings
- Type 1 ROP occurred in 20.0% with dexamethasone and 38.0% with placebo; adjusted odds ratio, 0.44 (95% CI, 0.17-1.12; P = .08).
- The trial reported a relative risk reduction of 47%, although the primary analysis did not reach statistical significance.
- No clinically significant differences in adverse events were observed between treatment groups.
Why it matters
Treatment-requiring ROP currently calls for invasive interventions intended to prevent blindness. A topical approach could offer a less invasive means of reducing progression in preterm infants, but this trial’s numerical difference was not statistically significant. The findings therefore add evidence about a potential strategy without establishing that dexamethasone drops prevent the need for treatment.
What to keep in mind
The trial included 100 infants, and the primary result was not statistically significant, with a confidence interval that included no effect.