Clinical trial NCT06885242: Efficacy and Safety of Cyclopentolate Microdrops for Cycloplegic Refraction in Children
Official title: Efficacy and Safety of Cyclopentolate Microdrops for Cycloplegic Refraction in Children: a Non-inferiority Crossover Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Cycloplegic Refraction
Keywords: microdrops
cycloplegia
refraction
cyclopentolate
children
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: Nanodropper, Inc.
First posted: 2025-03-20
Enrollment: 62
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Cycloplegic refraction: diopters of spherical equivalent
timeFrame: 40 minutes post-instillation
Secondary outcomes:
measure: Heart rate: bpm
timeFrame: 40 minutes post-instillation
measure: Flushing: absent, minor, major
timeFrame: 40 minutes post-instillation
measure: Behavioral changes: yes or no
timeFrame: 40 minutes post-instillation
measure: Sleepiness: yes or no
timeFrame: 40 minutes post-instillation
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital
Study officials:
References:
citation: 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 Feb 26. doi: 10.1007/s00417-025-06773-1. Online ahead of print.
citation: 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.
citation: Noske W. Cycloplegic refraction using atropine minidrops. Strabismus. 1993;1(1):17-23. doi: 10.3109/09273979309033849.