A Phase 4 interventional study of Microdrop instillation of cyclopentolate 1% and Standard drop instillation of cyclopentolate 1% in Cycloplegic Refraction, sponsored by Aristotle University Of Thessaloniki. Completed at 1 site in Greece. Open to participants aged 4 Years to 16 Years. Per ClinicalTrials.gov, last updated 2025-11-04.
Sponsored by Aristotle University Of Thessaloniki · Phase 4, Interventional, and Diagnostic
The purpose is to test the hypothesis that microdrop instillation of cyclopentolate 1% is non-inferior to standard of care, i.e., standard drop instillation of cyclopentolate 1%. Comparison, also, will be made to the subsequent adverse events.
A non-inferiority, crossover, randomized controlled trial will be conducted for this purpose. Participants will be randomly assigned to receive either a) microdrops on their first and standard drops on their second screening examination a week later (M/S group), or b) standard drops first and microdrops a week later (S/M group). Microdrops will be instilled using the Nanodropper® device, while standard drops will be instilled directly through the commercially available plastic multidose mydriatic dropper bottle. For all participants, the eyedrop will be firstly instilled in the right eye and this will be the eye that will be used for the analyses. Written informed consent will be obtained from the parents/guardians for the children's enrollment.
Aristotle University Of Thessaloniki is the lead sponsor of 274 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children aged 4-16 years old, who require cycloplegic refraction measurements in the context of regular ophthalmological examination as outpatients in the 2nd Department of Ophthalmology of AUTh at a tertiary center in Northern Greece.
Exclusion Criteria:
Cycloplegia with microdrops
Device: Microdrop instillation of cyclopentolate 1%
Cycloplegia with standard drops
Device: Standard drop instillation of cyclopentolate 1%
1 drop administered through the Nanodropper device adapted to the commercially available multi-dose dropper bottle
1 drop administered directly through the commercially available multi-dose dropper bottle
Cycloplegic refraction: diopters of spherical equivalent
The difference in spherical equivalent (SE) after microdrop and standard drop instillation (cycloplegic efficacy)
Time frame: 40 minutes post-instillation
Heart rate: bpm
The difference in heart rate after microdrop and standard drop instillation (safety outcome)
Time frame: 40 minutes post-instillation
Flushing: absent, minor, major
The difference in the number of patients who experience flushing after microdrop and after standard drop instillation (safety outcome)
Time frame: 40 minutes post-instillation
Behavioral changes: yes or no
The difference in the number of patients who experience behavioral changes after microdrop and after standard drop instillation (safety outcome)
Time frame: 40 minutes post-instillation
Sleepiness: yes or no
The difference in the number of patients who experience sleepiness after microdrop and standard drop instillation (safety outcome)
Time frame: 40 minutes post-instillation
Plan to share: Undecided
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Aristotle University Of Thessaloniki