Study on the Effectiveness and Safety of Atropine and DIMS Lenses for Myopia Control in Children

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What is this study about?

This clinical trial is focused on studying the condition known as myopia, which is commonly referred to as nearsightedness. Myopia is a vision problem where distant objects appear blurry while close objects can be seen clearly. The study is investigating the effectiveness and safety of a treatment that combines diluted atropine sulfate eye drops with special lenses called DIMS lenses. Atropine sulfate is a medication used in eye drops to help control the progression of myopia, and DIMS lenses are designed with a special technology to help manage this condition.

The purpose of the study is to determine how well this combination treatment works in slowing down the worsening of myopia in children. Participants in the study will use the atropine eye drops, which are applied as one drop per day, and wear the DIMS lenses. The study will monitor changes in the participants’ vision over time to see if the treatment helps in controlling myopia progression. The study will also keep track of any side effects that may occur during the treatment period.

The study will take place over a period of time, and participants will be regularly checked to assess their vision and eye health. This will include measuring changes in their eyesight and examining the thickness of certain parts of the eye using a method called Optical Coherence Tomography (OCT). The study aims to provide valuable information on whether this treatment can be a safe and effective option for managing myopia in children.

1 joining the study

The study involves children aged 4 to 16 years with myopia greater than -1.00 dioptres (D).

Consent is required from parents or guardians, and assent from children under 12 years old.

2 initial assessment

An initial eye examination is conducted to measure refractive error, axial length, and visual acuity.

Cycloplegia is induced using 1% cyclopentolate, administered as 3 drops, 10 minutes apart, with measurements taken after 30 minutes.

3 treatment phase

Participants receive diluted atropine eye drops at a concentration of 0.025%, applied ophthalmically.

DIMS technology lenses are also used to help control myopia progression.

The treatment continues throughout the study duration, with regular follow-up visits.

4 follow-up assessments

Regular follow-up visits are scheduled to monitor changes in refractive error, axial length, and intraocular pressure.

Optical Coherence Tomography (OCT) is used to measure changes in choroidal and retinal thickness.

5 completion of the study

The study is estimated to conclude by June 30, 2026.

Final assessments are conducted to evaluate the efficacy and safety of the treatment.

Who Can Join the Study?

Patients must be between 4 and 16 years old.
Parents or guardians must sign an informed consent form for all patients. For patients aged 12-16 years, they must also agree to participate. For children under 12, they need to give their agreement, known as assent.
Patients must have a vision condition called myopia, which means they are nearsighted, with a measurement greater than -1.00 dioptres (D). A dioptre is a unit that measures the focusing power of the eye.
There must be a worsening of myopia by at least -0.50 D in the last 12 months.
Patients can have astigmatism of 2 D or less. Astigmatism is when the eye is not perfectly round, causing blurred vision. They can also have anisometropia of 1.50 D or less, which means there is a difference in vision strength between the two eyes.
Patients must have a best-corrected monocular visual acuity (VA) of 0.2 logMAR (6/9) or better. This means that with glasses or contact lenses, each eye should see clearly enough to read a specific line on an eye chart.

Who Cannot Join the Study?

Patients who have any other eye conditions besides myopia (nearsightedness) cannot participate.
Patients who have had eye surgery in the past are not eligible.
Patients who are currently using other treatments for myopia are excluded.
Patients with allergies to any of the study medications or materials cannot join.
Patients with any serious health conditions that might affect the study results are not allowed to participate.
Patients who are unable to follow the study procedures or attend all required visits are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	16.02.2022

Trial locations

Investigated drugs:

Atropine Sulfate

Atropine is an eye drop medication used in this trial to help control the progression of myopia, or nearsightedness, in children. It works by relaxing certain muscles in the eye, which can help slow down the worsening of myopia over time.

DIMS Lenses are special ophthalmic lenses designed to help manage myopia in children. These lenses use a technology that helps to reduce the strain on the eyes and can slow down the progression of nearsightedness. They are worn like regular glasses and are part of the treatment being tested in this trial.

Investigated diseases:

Myopia

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 is too long or the cornea is too curved, causing light to focus in front of the retina instead of on it. This condition often begins in childhood and can progress as the eye continues to grow. As myopia progresses, the ability to see distant objects becomes increasingly impaired. It is typically identified through vision tests that measure how well one can see at various distances. Myopia is not considered a rare disease and affects a significant portion of the population worldwide.

Trial ID:

2024-514651-15-00

Protocol code:

01-DIMS-2021

NCT ID:

NCT06431841

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of Atropine and DIMS Lenses for Myopia Control in Children

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?