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

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.

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

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

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

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

The change in thickness of the crystalline lens, measured in millimeters (mm).

The change in depth of the vitreous cavity, measured in millimeters (mm)

The degree of heterophoria for distance vision, measured in prism diopters (PD).

The degree of heterophoria for near vision, measured in prism diopters (PD).

Visual quality and vision-related quality of life is assessed using the National Eye Institute Visual Function Questionnaire - 25 (NEI VFQ-25). The overall composite score ranges from 0 to 100, where a higher score represents better visual function and quality of life.

Cognitive function is assessed using the Montreal Cognitive Assessment (MoCA), a widely used screening test for cognitive impairment. The total score ranges from 0 to 30, with a score of 26 or higher considered normal. As probiotic supplementation may influence cognitive function, this will be considered in the interpretation of results.

Gastrointestinal symptoms are assessed using the Gastrointestinal Symptom Rating Scale (GSRS), a validated questionnaire covering reflux, abdominal pain, indigestion, diarrhea, and constipation. Each symptom is rated on a scale from 0 (no discomfort) to 6 (very severe discomfort). A higher total or subscale score indicates more severe gastrointestinal symptoms (worse outcome). As probiotic supplementation may influence gastrointestinal function, this will be considered in the interpretation of results.

Participant adaptation and overall quality of life are assessed using the World Health Organization Quality of Life Brief Version (WHOQOL-BREF), a validated generic quality of life instrument. It covers physical health, psychological health, social relationships, and environment domains. The total score is transformed to range from 0 to 100, where a higher score indicates a better quality of life and better adaptation. As probiotic supplementation may influence overall well-being, this will be considered in the interpretation of results.

Fecal samples collected before and after intervention are analyzed using full-length 16S rRNA gene sequencing. Key metrics include changes in alpha diversity indices (e.g., Shannon Index, observed species), beta diversity (e.g., weighted/unweighted UniFrac distance), and relative abundance of specific bacterial taxa (e.g., phylum Firmicutes/Bacteroidota ratio, genus Bifidobacterium).

Targeted metabolomic analysis is performed on fecal and blood serum samples. Concentrations of specific metabolites (e.g., short-chain fatty acids, bile acids, or inflammatory cytokines) are measured and reported in nanomolar (nM) or picograms per milliliter (pg/mL) concentrations, as applicable.