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Recruiting NCT07298824

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

Phase II Interventional Myopia Progressing

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Investigational Bifidobacterium Preparation MR-61, Placebo for MR-61.
Who it may be relevant to
Registry conditions: Myopia Progressing. Basic parameters: 3 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Clinical Efficacy and Mechanism Exploration of MR-61 in Delaying the Progression of Myopia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Overview

To investigate whether probiotic MR-61 can assist in slowing down the progression rate of myopia (a prospective randomized controlled study).

Detailed description

To investigate whether probiotic MR-61 can assist in slowing down the progression rate of myopia (a prospective randomized controlled study).

Interventions

  • Biological Investigational Bifidobacterium Preparation MR-61
    Oral administration of the investigational probiotic powder MR-61. The primary component is Bifidobacterium. Dosage: one sachet, 2-3 times daily, for 3 months.
  • Other Placebo for MR-61
    Oral administration of a matched placebo powder. Dosage: one sachet, 2-3 times daily, for 3 months.

Primary outcome measures

  • Change in Spherical Equivalent Refraction [Time frame: Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.]
Secondary outcome measures (12)
  • Change in Axial Length [Time frame: Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.]
  • Change in Corneal Curvature [Time frame: Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.]
  • Change in Binocular Anisometropia [Time frame: Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.]
  • Change in Anterior Chamber Depth [Time frame: Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.]
  • Change in Lens Thickness [Time frame: Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.]
  • Change in Vitreous Cavity Depth [Time frame: Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.]
  • Change in Far Phoria Degree [Time frame: Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.]
  • Change in Near Phoria Degree [Time frame: Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.]
  • Score on the National Eye Institute Visual Function Questionnaire - 25 (NEI VFQ-25) [Time frame: Assessed at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.]
  • Score on the Montreal Cognitive Assessment (MoCA) [Time frame: Assessed at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.]
  • Score on the Gastrointestinal Symptom Rating Scale (GSRS) [Time frame: Assessed at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.]
  • Score on the World Health Organization Quality of Life Brief Version (WHOQOL-BREF) [Time frame: Assessed at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Either or both parents having a spherical equivalent (SE) ≤ -6.00D;
  • Other conditions inconsistent with this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

China · 1 center
  • Yifeng Yu — Nanchang

Identifiers

NCT: NCT07298824 · IIT-I-2025-082

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗