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

Journal of Perinatology volume 42, pages 371–377 (2022)Cite this article

Subjects

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.

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Fig. 1: The microdrop instillation device and the ruler that were used in the present pilot study.
Fig. 2

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Authors and Affiliations

  1. 2nd Department of Ophthalmology, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece

    Aikaterini K. Seliniotaki, Nikolaos Ziakas & Asimina Mataftsi

  2. 2nd Department of Neonatology, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece

    Maria Lithoxopoulou & Elisavet Diamanti

  3. Department of Hygiene, Social-Preventive Medicine & Medical Statistics, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece

    Persefoni Talimtzi & Anna-Bettina Haidich

  4. Laboratory of Biological Chemistry, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece

    Elisavet Georgiou

Authors
  1. Aikaterini K. Seliniotaki
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  2. Maria Lithoxopoulou
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  3. Persefoni Talimtzi
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  4. Elisavet Georgiou
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  6. Nikolaos Ziakas
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  7. Anna-Bettina Haidich
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  8. Asimina Mataftsi
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Contributions

AKS, ML, EG, ABH, and AM contributed to the conception and design of the study. AKS was involved in the assignment of interventions. ML and AM were involved in the recruitment and screening of trial participants and data collection. AKS, PT, ABH, and AM performed data analysis. All authors (AKS, ML, PT, EG, ED, NZ, ABH, and AM) contributed to the interpretation of the data. AKS, PT and AM prepared the initial draft manuscript. All authors (AKS, ML, PT, EG, ED, NZ, ABH, and AM) were involved in the revision and edit of the manuscript. All authors (AKS, ML, PT, EG, ED, NZ, ABH, and AM) approved the final version to be published and are responsible for accuracy and integrity of all aspects of research.

Corresponding author

Correspondence to Asimina Mataftsi.

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The authors declare no competing interests.

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Seliniotaki, A.K., Lithoxopoulou, M., Talimtzi, P. et al. Efficacy and safety of mydriatic microdrops for retinopathy of prematurity screening: an external pilot crossover randomized controlled trial. J Perinatol 42, 371–377 (2022). https://doi.org/10.1038/s41372-021-01229-w

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