Efficacy and Safety of Cyclopentolate Microdrops for Cycloplegic Refraction in Children

Last updated: March 14, 2025
Sponsor: Aristotle University Of Thessaloniki
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

Standard drop instillation of cyclopentolate 1%

Microdrop instillation of cyclopentolate 1%

Clinical Study ID

NCT06885242
383/19-06-2024
  • Ages 4-16
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 thissolution

  4. Presence of any contraindication for the child to receive cyclopentolate eyedrops (e.g. neurological disease of concern)

Study Design

Total Participants: 62
Treatment Group(s): 2
Primary Treatment: Standard drop instillation of cyclopentolate 1%
Phase: 4
Study Start date:
September 06, 2024
Estimated Completion Date:
December 05, 2025

Study 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.

Connect with a study center

  • Papageorgiou General Hospital

    Thessaloniki,
    Greece

    Active - Recruiting

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