Status:
COMPLETED
Efficacy and Safety of Cyclopentolate Microdrops for Cycloplegic Refraction in Children
Lead Sponsor:
Aristotle University Of Thessaloniki
Collaborating Sponsors:
Nanodropper, Inc.
Conditions:
Cycloplegic Refraction
Eligibility:
All Genders
4-16 years
Phase:
PHASE4
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, wil...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2025
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT06885242
Start Date
September 6 2024
End Date
October 8 2025
Last Update
November 4 2025
Active Locations (1)
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1
Papageorgiou General Hospital
Thessaloniki, Greece