Efficacy and safety of mydriatic microdrops for retinopathy of prematurity screening: an external pilot crossover randomized controlled trial

J Perinatol. 2022 Mar;42(3):371-377. doi: 10.1038/s41372-021-01229-w. Epub 2021 Oct 15.

Abstract

Objective: To study the efficacy and safety of mydriatic microdrops compared with standard drops for retinopathy of prematurity (ROP) screening.

Study design: Preterm infants undergoing ROP screening received microdrops and standard drops of phenylephrine 1.67% and tropicamide 0.33% in a random allocation sequence at two consecutive weekly examinations. Primary outcome was pupil diameter measured by two masked observers at 45 (T45) and 90 (T90) minutes after instillation.

Results: Twenty-five infants were randomized. No differences observed in mean pupil diameter after either administration technique at all time points (T45 Mean Difference: -0.14; 95% Confidence Interval: -0.38, 0.09; p = 0.23). Heart rate values at T120 were lower after microdrop instillation (p = 0.046). Otherwise, adverse events did not differ after either administration technique.

Conclusion: This pilot study provides evidence of microdrops mydriasis efficacy, while justifying a full-scale trial to confirm their non-inferiority compared with standard drops and provide more data about safety.

Trial registration: ClinicalTrials.gov: NCT04623684.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Heart Rate
  • Humans
  • Infant
  • Infant, Newborn
  • Infant, Premature
  • Mydriatics* / adverse effects
  • Ophthalmic Solutions / adverse effects
  • Phenylephrine / adverse effects
  • Pilot Projects
  • Retinopathy of Prematurity* / diagnosis
  • Tropicamide / adverse effects

Substances

  • Mydriatics
  • Ophthalmic Solutions
  • Phenylephrine
  • Tropicamide

Associated data

  • ClinicalTrials.gov/NCT04623684