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Efficacy and safety of mydriatic microdrops for retinopathy of prematurity screening: an external pilot crossover
Aikaterini K Seliniotaki1, Maria Lithoxopoulou2, Persefoni Talimtzi3
12nd Department of Ophthalmology, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece.
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.
Insights
Mydriatic microdrops showed similar pupil dilation efficacy compared to standard drops for retinopathy of prematurity screening in preterm infants. This pilot study suggests microdrops are a safe alternative, warranting further investigation.
Area of Science:
- Ophthalmology
- Neonatology
- Clinical Pharmacology
Background:
- Retinopathy of prematurity (ROP) is a leading cause of blindness in premature infants.
- Effective ROP screening requires adequate pupil dilation.
- Current standard mydriatic drops may cause systemic side effects.
Purpose of the Study:
- To compare the efficacy and safety of mydriatic microdrops versus standard drops for ROP screening.
- To evaluate pupil diameter and adverse events following different administration techniques.
- To provide preliminary data for a larger, full-scale trial.
Main Methods:
- A randomized pilot study involving preterm infants undergoing ROP screening.
- Comparison of phenylephrine 1.67% and tropicamide 0.33% administered as microdrops or standard drops.
- Pupil diameter was measured at 45 and 90 minutes post-instillation by masked observers.
Main Results:
- No significant difference in mean pupil diameter was observed between microdrops and standard drops at any time point.
- Heart rate was lower at 120 minutes after microdrop instillation.
- No significant differences in adverse events were noted between the two methods.
Conclusions:
- Mydriatic microdrops are effective for pupil dilation in ROP screening.
- Microdrop administration appears safe and comparable to standard drops.
- Further large-scale trials are needed to confirm non-inferiority and safety.
