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Efficacy and Safety of Cyclopentolate Microdrops for Cycloplegic Refraction in Children

NCT06885242 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2025-11-04

No results posted yet for this 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.

Conditions

  • Cycloplegic Refraction

Interventions

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

Sponsors & Collaborators

  • Nanodropper, Inc.

    collaborator INDUSTRY

  • Aristotle University Of Thessaloniki

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
4 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-06
Primary Completion
2025-09-26
Completion
2025-10-08
FDA Device
Yes

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06885242 on ClinicalTrials.gov