Study on the Effects of Atropine Sulfate Monohydrate Eye Drops in Slowing Myopia Progression in Children

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for myopia, commonly known as nearsightedness, in children. The treatment being tested involves eye drops containing a substance called atropine sulfate monohydrate. Two different concentrations of these eye drops, Atropini collyrium 0.02% and Atropini collyrium 0.04%, are being compared to a placebo to see how well they work in slowing down the progression of myopia.

The purpose of the study is to determine if these eye drops can effectively slow the growth of the eye, which is a key factor in the progression of myopia. Children participating in the study will use the eye drops daily over a period of up to two years. During this time, they will have regular check-ups every six months to monitor changes in their vision and eye health. The study will also look at any side effects that might occur from using the eye drops.

Throughout the study, researchers will measure changes in the length of the eye, known as axial eye length, and other aspects of eye health. The study aims to provide valuable information on whether these low-dose atropine eye drops can be a safe and effective treatment option for children with myopia, potentially helping to manage this common vision problem more effectively.

1 joining the study

Upon joining the study, the patient will be randomly assigned to one of three groups. Each group will receive different eye drops: Atropini collyrium 0.04%, Atropini collyrium 0.02%, or a placebo collyrium.

The study is designed to be double-blinded, meaning neither the patient nor the researchers will know which treatment the patient is receiving.

2 administration of eye drops

The patient will apply the assigned eye drops daily. The eye drops are administered through ocular use, which means they are applied directly to the eyes.

The duration of this daily application is set for a period of 24 months.

3 clinical examinations

Clinical examinations will occur every six months throughout the study period.

These examinations will assess various aspects of eye health, including axial eye length (AXL), visual acuity, and other growth characteristics of the eye.

4 keeping a diary

The patient, with the help of their parents or legal guardian, will maintain a weekly diary.

This diary will record the daily application of eye drops and any side effects or changes in vision experienced.

5 end of study

The study is expected to conclude by December 31, 2025.

At the end of the study, the collected data will be analyzed to determine the effectiveness and safety of the atropine eye drops in slowing the progression of myopia in children.

Who Can Join the Study?

Children aged 6 to 12 years old.
Must have been diagnosed with myopia (nearsightedness) with a specific range of vision measurements: -0.5 to -4.75 for the spherical component and 0 to -2.5 for astigmatism in at least one eye.
Vision in the worse eye should be better or equal to a specific level measured by a test called logMAR.
Specific measurements from a test called corneal topography should be within certain limits in at least one eye.
Both eyes should have normal findings and history, except for needing glasses or having had minor eye issues like conjunctivitis.
Both eyes should have normal binocular functions, which means they work well together, except for a condition called exophoria that is within a certain range.
Normal intraocular pressure (pressure inside the eyes) should be 22 or less in both eyes.
There should be a specific amount of growth in the length of the eye (called AXL growth) over a certain period before joining the study, based on the child’s age.
The child and their parents or legal guardian must be willing to apply eye drops daily for two years, attend clinical exams every six months for three years, and keep a diary weekly during this time.

Who Cannot Join the Study?

Children who are not diagnosed with myopia (nearsightedness) cannot participate.
Children outside the specified age range for the study cannot participate.
Children with any other eye conditions that might affect the study results cannot participate.
Children who have had previous eye surgeries cannot participate.
Children who are currently using other eye medications cannot participate.
Children with allergies to the study medication or similar substances cannot participate.
Children with any serious health conditions that might interfere with the study cannot participate.
Children who are unable to attend all required study visits cannot participate.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Fakultni Nemocnice Brno	Brno	Czechia
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Bhusukldb svgqoc	Litomysl	Czechia
Fmpibawi nbmxclhob Mhunu a Hmnvrwv	Prague	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	01.09.2021

Trial locations

Investigated drugs:

Atropine Sulfate Monohydrate

Atropine Collyrium is an eye drop solution used in this clinical trial to slow down the progression of myopia, or nearsightedness, in children. The study aims to evaluate the effectiveness, safety, and side effects of this medication. Atropine works by relaxing certain muscles in the eye, which may help in reducing the rate at which myopia worsens.

Investigated diseases:

Myopia

Myopia in children – Myopia, also known as nearsightedness, is a common vision condition where distant objects appear blurry while close objects can be seen clearly. In children, myopia typically develops when the eyeball grows too long or the cornea is too curved, causing light to focus in front of the retina instead of on it. This condition often progresses as children grow, with the degree of nearsightedness increasing over time. Myopia can lead to difficulties in seeing the board at school or recognizing distant objects. The progression of myopia in children can vary, with some experiencing rapid changes in their vision, while others may have a more gradual progression. Environmental factors, such as time spent outdoors and activities involving close-up work, can influence the development and progression of myopia in children.

Trial ID:

2024-515888-54-00

Protocol code:

MARS_2020

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Atropine Sulfate Monohydrate Eye Drops in Slowing Myopia Progression in Children

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?