NCT07298824RecruitingPhase 2
Clinical Efficacy and Mechanism Exploration of MR-61 in Delaying the Progression of Myopia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Second Affiliated Hospital of Nanchang University1 site in 1 country164 target enrollmentStarted: October 1, 2025Last updated:
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 164
- Locations
- 1
- Primary Endpoint
- Change in Spherical Equivalent Refraction
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 3 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Probiotic group
Active Comparator
Oral administration of the investigational probiotic powder MR-61. The primary component is Bifidobacterium. Dosage: one sachet, 2-3 times daily, for 3 months.
Intervention: Investigational Bifidobacterium Preparation MR-61 (Biological)
Placebo group
Placebo Comparator
Oral administration of a matched placebo powder. Dosage: one sachet, 2-3 times daily, for 3 months.
Intervention: Placebo for MR-61 (Other)
Outcomes
Primary Outcomes
Change in Spherical Equivalent Refraction
Time Frame: Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.
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 Near Phoria Degree(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)(Assessed at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.)
- Score on the Montreal Cognitive Assessment (MoCA)(Assessed at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.)
- Score on the Gastrointestinal Symptom Rating Scale (GSRS)(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)(Assessed at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.)
- Change in gut microbiota composition and diversity assessed by 16S rRNA gene sequencing(Fecal samples collected at baseline, 3, 6, 12, and 25 months post-intervention for sequencing analysis.)
- Change in concentrations of fecal and serum metabolites(Fecal and blood serum samples collected at baseline, 3, 6, 12, and 25 months post-intervention for metabolite analysis.)
- Change in Axial Length(Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.)
- Change in Corneal Curvature(Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.)
- Change in Binocular Anisometropia(Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.)
- Change in Anterior Chamber Depth(Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.)
- Change in Lens Thickness(Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.)
- Change in Vitreous Cavity Depth(Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.)
- Change in Far Phoria Degree(Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.)
Investigators
Yifeng Yu
Associate Chief Physician, Ph.D.
Second Affiliated Hospital of Nanchang University
Study Sites (1)
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