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Tiny eye drops could make Kids' eye exams safer

NCT ID NCT06885242

Symptom relief Sponsor: Aristotle University Of Thessaloniki Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether using a special device to give smaller drops of cyclopentolate (a drug that dilates pupils) works as well as standard drops for children's eye exams. 63 children aged 4-16 received both types of drops on different visits. The goal was to see if the smaller drops cause fewer side effects like fast heart rate or facial flushing while still being effective for measuring vision.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cyclopentolate 1% eye drops
What this could lead to
If microdrops work as well as standard drops, children may experience fewer side effects like fast heart rate or flushing during eye exams.
What could go wrong
This is a small, completed Phase 4 trial with only 63 children. The microdrop device may not be widely available, and results may not apply to all children or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

63 people

The number who actually took part.

Started

Sep 2024

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

4 to 16 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cycloplegic refraction

Contacts and locations

Locations

  • Papageorgiou General Hospital

    Thessaloniki, Greece

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