Dexamethasone eye drops reduce the risk of prethreshold retinopathy of prematurity progressing to treatment-requiring type 1 ROP in preterm infants, according to a randomized clinical trial published online August 3 in JAMA Pediatrics.
Clinical Trial Design and Findings
Led by Ann Hellström, M.D., Ph.D., from the University of Gothenburg in Sweden, researchers conducted a double-masked, randomized clinical trial involving 100 infants born before 30 weeks of gestational age. Participants showed signs of severe retinopathy of prematurity (ROP). The study assigned infants equally to receive either dexamethasone eye drops at a concentration of 1 mg/mL or a saline placebo for up to 12 weeks, with 50 infants in each group, according to reporting by HealthDay.
In the intention-to-treat population, type 1 ROP developed in 20.0 percent of infants in the dexamethasone group compared to 38.0 percent in the placebo group. This outcome yielded an adjusted odds ratio of 0.44 and a 47 percent relative risk reduction. Among the per-protocol population, type 1 ROP occurred in 18.8 percent of the dexamethasone cohort versus 38.8 percent of the control cohort.
Researchers noted no clinically significant differences in adverse events between the two study arms. Hellström stated that the results are promising because the intervention is simple, inexpensive, and noninvasive, enabling clinicians to reduce the need for laser and ocular injections in fragile premature infants.
Understanding Retinopathy of Prematurity
Retinopathy of prematurity occurs in premature babies.
Frequently Asked Questions
What is type 1 ROP?
Type 1 retinopathy of prematurity is a stage of the disease that requires treatment.
How were the dexamethasone eye drops administered?
In the trial reported by HealthDay, infants received 1 mg/mL dexamethasone eye drops or a saline placebo for a duration of up to 12 weeks.
Were there notable side effects?
Researchers found no clinically significant differences in adverse events between the infants receiving dexamethasone and those receiving the placebo.