Efficacy and Safety of Cyclopentolate Microdrops for Cycloplegic Refraction in Children

NCT06885242 | Completed Phase 4 FDA Device

• 1 other identifier: 383/19-06-2024
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Cycloplegic Refraction

Keywords

microdrops; cycloplegia; refraction; cyclopentolate; children

Outcome Measures

Primary Outcomes (1)

• Cycloplegic refraction: diopters of spherical equivalent

  The difference in spherical equivalent (SE) after microdrop and standard drop instillation (cycloplegic efficacy)

  40 minutes post-instillation

Secondary Outcomes (4)

• Heart rate: bpm

  40 minutes post-instillation

• Flushing: absent, minor, major

  40 minutes post-instillation

• Behavioral changes: yes or no

  40 minutes post-instillation

• Sleepiness: yes or no

  40 minutes post-instillation

Study Arms (2)

Study Group

EXPERIMENTAL

Cycloplegia with microdrops

Device: Microdrop instillation of cyclopentolate 1%

Control Group

ACTIVE COMPARATOR

Cycloplegia with standard drops

Device: Standard drop instillation of cyclopentolate 1%

Interventions

Microdrop instillation of cyclopentolate 1% DEVICE

1 drop administered through the Nanodropper device adapted to the commercially available multi-dose dropper bottle

Study Group

Standard drop instillation of cyclopentolate 1% DEVICE

1 drop administered directly through the commercially available multi-dose dropper bottle

Control Group

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Inability for the child to cooperate with autorefractometer
• Difficulties for the family to attend the follow-up visit
• Known allergic reaction to cyclopentolate or to any of the other ingredients of this solution
• Presence of any contraindication for the child to receive cyclopentolate eyedrops (e.g. neurological disease of concern)

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• Nanodropper, Inc.: collaborator

Study Sites (1)

Papageorgiou General Hospital

Thessaloniki, Greece

Location

Related Publications (3)

• 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.

  PMID: 40011238 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.

  PMID: 36280185 BACKGROUND

• Noske W. Cycloplegic refraction using atropine minidrops. Strabismus. 1993;1(1):17-23. doi: 10.3109/09273979309033849.

  PMID: 21314515 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Ophthalmology, Paediatric Ophthalmology and Strabismus

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 20, 2025
• Study Start: September 6, 2024
• Primary Completion: September 26, 2025
• Study Completion: October 8, 2025
• Last Updated: November 4, 2025

Record last verified: 2025-11

Locations

GR (1)