NCT06885242

Efficacy and Safety of Cyclopentolate Microdrops for Cycloplegic Refraction in Children

Efficacy and Safety of Cyclopentolate Microdrops for Cycloplegic Refraction in Children: a Non-inferiority Crossover Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Aristotle University Of Thessaloniki · Academic / Other
• Sex: All
• Age: 4 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cycloplegic Refraction

Interventions

Type	Name	Description
DEVICE	Microdrop instillation of cyclopentolate 1%	1 drop administered through the Nanodropper device adapted to the commercially available multi-dose dropper bottle
DEVICE	Standard drop instillation of cyclopentolate 1%	1 drop administered directly through the commercially available multi-dose dropper bottle

Timeline

• Start date: 2024-09-06
• Primary completion: 2025-09-26
• Completion: 2025-10-08
• First posted: 2025-03-20
• Last updated: 2025-11-04

Locations

1 site across 1 country: Greece

Regulatory

• FDA-regulated device study