About this trial
To investigate whether probiotic MR-61 can assist in slowing down the progression rate of myopia (a prospective randomized controlled study).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Myopia is defined as spherical equivalent (SE) ≤ -0.5D.
Aged between 3 and 18 years, with no restriction on gender.
Cylinder power ≤ 1.50D; anisometropia of SE between both eyes ≤ 1.50D.
The subject has sufficient compliance with the study follow-up; the subject or their guardian has the intention to receive treatment and has signed the informed consent form.
Disqualifiers
Presence of other concomitant ocular diseases;
Abnormal findings on clinical slit-lamp examination;
Existence of amblyopia, manifest strabismus, esotropia, or other congenital ocular diseases;
Individuals with abnormal intraocular pressure or abnormal axial length of the eye;
Trial design
Parallel
Treatments tested in this trial
Investigational Bifidobacterium Preparation MR-61
Biological/VaccineOral administration of the investigational probiotic powder MR-61. The primary component is Bifidobacterium. Dosage: one sachet, 2-3 times daily, for 3 months.
Placebo for MR-61
Other interventionOral administration of a matched placebo powder. Dosage: one sachet, 2-3 times daily, for 3 months.
Treatment groups
Trial outcomes
Primary outcomes
Change in Spherical Equivalent Refraction
The change in spherical equivalent refraction (SER) from baseline to each follow-up visit, measured in diopters (D). SER is calculated as the spherical power plus half of the cylindrical power. A negative change indicates an increase in myopia.
Secondary outcomes
Change in Axial Length
The growth value of ocular axial length, measured in millimeters (mm).
Change in Corneal Curvature
The change in corneal curvature (keratometry), measured in diopters (D).
Change in Binocular Anisometropia
The difference in spherical equivalent refraction between the two eyes, measured in diopters (D).
Change in Anterior Chamber Depth
The change in depth of the anterior chamber of the eye, measured in millimeters (mm).
Sponsors and contacts
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