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Study on Low-Dose Atropine Sulfate Eye Drops for Controlling Progressive Myopia in Caucasian 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 progressive myopia, a condition where a child's vision becomes increasingly nearsighted over time. The study will use Atropine Sulfate eye drops in two different low doses: 0.02% and 0.01%. These eye drops are designed to be used in the eyes to help control the progression of myopia in children.

The purpose of the study is to determine if the 0.02% dose of Atropine Sulfate is more effective than a placebo in slowing down the worsening of myopia in children of Caucasian origin. The study will last for one year, during which the changes in the children's vision will be monitored. The children participating in the study will receive either the 0.02% atropine eye drops, the 0.01% atropine eye drops, or a placebo.

Throughout the study, the main focus will be on measuring how much the children's vision changes over the year. This will be done by checking the change in their eye prescription, known as cycloplegic refraction, and the length of their eyes. The study aims to provide valuable information on whether low-dose Atropine Sulfate can effectively control myopia progression in children.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, ensure that you meet the eligibility criteria. You should be between 8 to 12 years old, have myopia ranging from -1 D to -6 D, and have experienced a progression of at least 0.5 D per year. Written consent from you and your parents or legal guardians is required.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate your eye health and confirm your eligibility. This includes measuring your current eye prescription and eye length.
Step 3
Medication administration
You will be provided with Atropine Sulfate 0.02% eye drops for use. These are to be administered once daily in each eye. The duration of this treatment is one year.
Step 4
Regular follow-up visits
Regular follow-up visits will be scheduled to monitor your progress. During these visits, your eye prescription and eye length will be measured to assess any changes.
Step 5
Final assessment
At the end of the one-year treatment period, a final assessment will be conducted. This will include measuring the change in your eye prescription and eye length over the year.

Who can join the trial?

6 criteria

Children who are 8 to 12 years old (up to the day before their 13th birthday).
Have progressive myopia, which means their nearsightedness is getting worse over time.
Have a level of myopia between -1 D to -6 D (this is a measure of how strong their glasses or contact lenses need to be).
Have a history of their myopia getting worse by at least 0.5 D per year.
Both the child and their parents or legal guardians must give written informed consent, which means they agree to participate after understanding what the study involves.
The child must be able to understand the trial and what it involves, and be able to follow the instructions given during the study.

Who cannot join the trial?

6 criteria

Patients with any eye condition other than progressive myopia (a condition where the eye grows too long, causing distant objects to appear blurry) cannot participate.
Patients who have had any eye surgery in the past.
Patients who are currently using any medication that affects the eyes, other than the study medication.
Patients with a known allergy to atropine (a medication used to dilate the pupil and relax the eye muscles).
Patients with any serious health condition that might interfere with the study.
Patients who are unable to follow the study procedures or attend the required visits.

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Verified sites

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Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH
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Ulm, Germany
Klinikum der Universitaet Muenchen AöR
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Munich, Germany
Medical Center - University Of Freiburg
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Freiburg Im Breisgau, Germany

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Investigated drugs

Atropine is a medication used in this clinical trial to help control myopia, which is also known as nearsightedness, in children. Myopia is a condition where distant objects appear blurry because the eye grows too long, causing light to focus in front of the retina instead of on it. Atropine eye drops work by relaxing certain muscles in the eye, which can help slow down the progression of myopia. In this trial, the focus is on using a low-dose version of atropine to see if it is more effective than a placebo in controlling myopia in children over a year.

Atropine Sulfate

What is already known about the treatment

Atropine – Atropine is administered in the form of eye drops, specifically at a low dose of 0.02%, and is applied directly to the eyes. It is currently being studied for its effectiveness in controlling progressive myopia, or nearsightedness, in children. The main therapeutic indication for atropine in this context is to slow down the progression of myopia. 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 worsening myopia. It is classified pharmacologically as an antimuscarinic agent.

Investigated diseases

Progressive myopia – Progressive myopia is a condition where the eye elongates over time, causing distant objects to appear blurry. It typically begins in childhood and can worsen as the child grows. The elongation of the eyeball leads to light focusing in front of the retina instead of directly on it. This condition can result in a gradual increase in the degree of nearsightedness. As the eye continues to grow, the myopia progresses, often stabilizing in adulthood. The progression rate can vary among individuals, influenced by genetic and environmental factors.