Efficacy and Safety of Cyclopentolate Microdrops for Cycloplegic Refraction in Children

Phase 4

Recruiting

• Conditions: Cycloplegic Refraction

• Registration Number: NCT06885242
• Lead Sponsor: Aristotle University Of Thessaloniki

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.

Study Timeline

• Study Start: 2024-09-06
• Status Verified: 2025-03
• Study First Submitted: 2025-03-14
• Study First Submitted QC: 2025-03-14
• Last Update Submitted: 2025-03-14
• Study First Posted: 2025-03-20
• Last Update Posted: 2025-03-20
• Primary Completion: 2025-11-28
• Study Completion: 2025-12-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 62

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Papageorgiou General Hospital; 🇬🇷 Thessaloniki, Greece