Efficacy and Safety of Cyclopentolate Microdrops for Cycloplegic Refraction in Children

Aristotle University Of Thessaloniki

Status and phase: Completed; Phase 4

Conditions: Cycloplegic Refraction

Treatments: Device: Standard drop instillation of cyclopentolate 1%; Device: Microdrop instillation of cyclopentolate 1%

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06885242

383/19-06-2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 4 to 16 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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63 participants in 2 patient groups

Study Group

Experimental group

Description:

Cycloplegia with microdrops

Treatment:

Device: Microdrop instillation of cyclopentolate 1%

Control Group

Active Comparator group

Description:

Cycloplegia with standard drops

Treatment:

Device: Standard drop instillation of cyclopentolate 1%