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| Name | Class |
|---|---|
| Nanodropper, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | Cycloplegia with microdrops |
|
| Control Group | Active Comparator | Cycloplegia with standard drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microdrop instillation of cyclopentolate 1% | Device | 1 drop administered through the Nanodropper device adapted to the commercially available multi-dose dropper bottle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cycloplegic refraction: diopters of spherical equivalent | The difference in spherical equivalent (SE) after microdrop and standard drop instillation (cycloplegic efficacy) | 40 minutes post-instillation |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate: bpm | The difference in heart rate after microdrop and standard drop instillation (safety outcome) | 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) |
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Inclusion Criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Papageorgiou General Hospital | Thessaloniki | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40011238 | Background | Seliniotaki AK, Tziola T, Lithoxopoulou M, Tzamalis A, Ziakas N, Mataftsi A. Optimizing instilled drug delivery: a scoping review of microdrops in ophthalmology. Graefes Arch Clin Exp Ophthalmol. 2025 Jul;263(7):1765-1787. doi: 10.1007/s00417-025-06773-1. Epub 2025 Feb 26. | |
| 36280185 | Background | Hoppe CB, Yonamine S, Kao BW, Turner ML, Ou Y, Han Y, Keenan JD, Oatts JT. Randomized Trial to Evaluate the Efficacy of the Nanodropper Device for Pupillary Dilation and Cycloplegia in Children. Ophthalmology. 2023 Mar;130(3):324-330. doi: 10.1016/j.ophtha.2022.10.016. Epub 2022 Oct 22. |
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| Standard drop instillation of cyclopentolate 1% | Device | 1 drop administered directly through the commercially available multi-dose dropper bottle |
|
| 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) | 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) | 40 minutes post-instillation |
| 21314515 | Background | Noske W. Cycloplegic refraction using atropine minidrops. Strabismus. 1993;1(1):17-23. doi: 10.3109/09273979309033849. |