Efficacy and Safety of Cyclopentolate Microdrops for Cycloplegic Refraction in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-06

Study Completion Date

2025-10-08

Brief Summary

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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.

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Detailed Description

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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

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Cycloplegic Refraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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Study Group

Cycloplegia with microdrops

Group Type EXPERIMENTAL

Microdrop instillation of cyclopentolate 1%

Intervention Type DEVICE

1 drop administered through the Nanodropper device adapted to the commercially available multi-dose dropper bottle

Control Group

Cycloplegia with standard drops

Group Type ACTIVE_COMPARATOR

Standard drop instillation of cyclopentolate 1%

Intervention Type DEVICE

1 drop administered directly through the commercially available multi-dose dropper bottle

Interventions

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Standard drop instillation of cyclopentolate 1%

1 drop administered directly through the commercially available multi-dose dropper bottle

Intervention Type DEVICE

Microdrop instillation of cyclopentolate 1%

1 drop administered through the Nanodropper device adapted to the commercially available multi-dose dropper bottle

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

4 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No