Clinical Efficacy and Mechanism Exploration of MR-61 in Delaying the Progression of Myopia

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age3-18
SponsorSecond Affiliated Hospital of Nanchang University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Investigational Bifidobacterium Preparation MR-61

    Biological/Vaccine

    Oral 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 intervention

    Oral administration of a matched placebo powder. Dosage: one sachet, 2-3 times daily, for 3 months.

Treatment groups

164 Participants
are divided into 2 treatment groups
Group A: Probiotic groupActive comparator 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.

Secondary outcomes

1

Change in Axial Length

The growth value of ocular axial length, measured in millimeters (mm).

Time frame
Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.
2

Change in Corneal Curvature

The change in corneal curvature (keratometry), measured in diopters (D).

Time frame
Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.
3

Change in Binocular Anisometropia

The difference in spherical equivalent refraction between the two eyes, measured in diopters (D).

Time frame
Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.
4

Change in Anterior Chamber Depth

The change in depth of the anterior chamber of the eye, measured in millimeters (mm).

Time frame
Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.

Other outcomes

Sponsors and contacts

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