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Study on Atropine Sulfate Eye Drops to Slow Down Myopia in European Children

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the progression of myopia, commonly known as nearsightedness, in children. The study aims to find the best dose of atropine sulfate eye drops to slow down the worsening of myopia. Atropine sulfate is a medication used in eye drops to help relax the eye muscles and is being tested in different low doses: 0.05%, 0.025%, 0.01%, and 0.005%. A placebo eye drop, which does not contain the active medication, is also used for comparison.

The purpose of the study is to determine the most effective dose of atropine sulfate eye drops for reducing the progression of myopia in children. Participants in the study will receive one of the different doses of atropine sulfate eye drops or a placebo. The study will last for about a year, during which the children will have regular check-ups to monitor changes in their vision and eye health. These check-ups will include measuring the growth of the eye, the depth of the front part of the eye, and other aspects of eye function.

Throughout the study, the safety of the atropine sulfate eye drops will be closely monitored. This includes checking for any side effects that might occur in the eyes or elsewhere in the body. The study will also look at how the eye drops affect different eye colors, as well as any changes in vision clarity and eye pressure. The goal is to ensure that the treatment is both effective and safe for children with myopia.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
The study involves children aged 6 to 12 years with myopia, a condition where distant objects appear blurry.
Participants must have shown myopia progression in the past year and meet specific vision criteria.
Parents or guardians must provide consent for participation.
Step 2
Randomization and treatment assignment
Participants are randomly assigned to receive one of the following treatments: atropine sulfate eye drops at concentrations of 0.005%, 0.01%, 0.025%, 0.05%, or a placebo.
The study is double-blind, meaning neither the participants nor the researchers know which treatment is being administered.
Step 3
Administration of eye drops
Eye drops are administered topically, meaning they are applied directly to the eyes.
The frequency and duration of administration are determined by the study protocol and are consistent for all participants.
Step 4
Monitoring and assessments
Participants undergo regular assessments to monitor changes in myopia over a 12-month period.
Primary assessments include measuring changes in vision using an autorefractor, a device that measures how light is changed as it enters the eye.
Step 5
Secondary assessments
Additional assessments include measuring eye growth, lens thickness, pupil size, and visual acuity.
The effects of atropine on different eye characteristics, such as iris pigmentation, are also evaluated.
Step 6
Safety monitoring
Safety is monitored by checking for any adverse reactions to the eye drops, both locally in the eye and systemically throughout the body.
Participants and caregivers report any side effects, and investigators assess these reports.
Step 7
Completion of the study
The study is expected to conclude in June 2025, after which the data will be analyzed to determine the optimal dose of atropine for inhibiting myopia progression.

Who can join the trial?

5 criteria

Children who are boys or girls, aged between 6 and 12 years old.
Girls who have started their menstrual cycle must use a very effective method to prevent pregnancy, with a failure rate of less than 1% per year.
Children must have **myopia** (nearsightedness) with a measurement between -1.0 and -4.0 **diopters** (a unit to measure the strength of glasses or contact lenses) in at least one eye.
There must be a noticeable worsening of myopia in the past year in at least one eye.
Parents or legal guardians must be informed about the study and must sign a form agreeing to let their child participate.

Who cannot join the trial?

6 criteria

Children who have any eye diseases other than **myopia** (nearsightedness) cannot participate.
Children who have had eye surgery in the past cannot participate.
Children who are currently using other eye medications cannot participate.
Children with allergies to **atropine** or any of its ingredients cannot participate. **Atropine** is a medication used in eye drops.
Children with any serious health conditions that might affect the study cannot participate.
Children who are not able to follow the study instructions cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Internationale Innovative Ophthalmochirurgie GbR (I.I.O.)
Verified
Duesseldorf, Germany
Kardiologie im Spreebogen
Verified
Berlin, Germany
Saarland University Hospital
Verified
Homburg, Germany

Trial locations

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Investigated drugs

Atropine Eye Drops are being studied to find the best dose to slow down the progression of myopia, which is also known as nearsightedness, in children. These eye drops are used in low doses to help prevent the eyes from getting worse over time. The study is testing different strengths of atropine to see which one works best for children in a European population.

What is already known about the treatment

Atropine – Atropine is administered in the form of eye drops and is applied directly to the eyes. It is currently being studied in clinical trials to determine its effectiveness in slowing the progression of myopia in children. The main therapeutic indication for atropine in this context is to inhibit the worsening of nearsightedness. At the molecular level, atropine works by blocking certain receptors in the eye, which helps to reduce the elongation of the eyeball that leads to myopia. It is classified pharmacologically as an antimuscarinic agent.

Investigated diseases

Myopia – Myopia, also known as nearsightedness, is a common vision condition where distant objects appear blurry while close objects can be seen clearly. It occurs when the eye grows too long from front to back, causing light rays to focus in front of the retina instead of directly on it. This condition often begins in childhood and can progress as the child grows. The progression of myopia can lead to an increase in the degree of nearsightedness, requiring stronger corrective lenses over time. Factors such as genetics and environmental influences, like prolonged near work or limited outdoor activities, can contribute to its development. Regular eye examinations are important to monitor changes in vision and eye health.