Cycloplegic Refraction
Conditions
Keywords
microdrops, cycloplegia, refraction, cyclopentolate, children
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMicrodrop instillation of cyclopentolate 1%
1 drop administered through the Nanodropper device adapted to the commercially available multi-dose dropper bottle
DEVICEStandard drop instillation of cyclopentolate 1%
1 drop administered directly through the commercially available multi-dose dropper bottle
Sponsors
Nanodropper, Inc.
Aristotle University Of Thessaloniki
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 16 Years
Healthy volunteers
No
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
1. Inability for the child to cooperate with autorefractometer 2. Difficulties for the family to attend the follow-up visit 3. Known allergic reaction to cyclopentolate or to any of the other ingredients of this solution 4. Presence of any contraindication for the child to receive cyclopentolate eyedrops (e.g. neurological disease of concern)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cycloplegic refraction: diopters of spherical equivalent | 40 minutes post-instillation | The difference in spherical equivalent (SE) after microdrop and standard drop instillation (cycloplegic efficacy) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate: bpm | 40 minutes post-instillation | The difference in heart rate after microdrop and standard drop instillation (safety outcome) |
| Flushing: absent, minor, major | 40 minutes post-instillation | The difference in the number of patients who experience flushing after microdrop and after standard drop instillation (safety outcome) |
| Behavioral changes: yes or no | 40 minutes post-instillation | The difference in the number of patients who experience behavioral changes after microdrop and after standard drop instillation (safety outcome) |
| Sleepiness: yes or no | 40 minutes post-instillation | The difference in the number of patients who experience sleepiness after microdrop and standard drop instillation (safety outcome) |
Countries
Greece
Outcome results
None listed