A clinical study of VisionGuard Pro nutritional jelly for slowing myopia progression in children

A 12-Week, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Evaluate the Efficacy and Safety of VisionGuard Pro Marine Collagen-Based Nutritional Jelly in Children With Progressive Myopia - VisionGuard Pro in myopic children: efficacy and safety

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000059247

Enrollment

Registered

2025-10-01

Start date

2026-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Progressive myopia in children aged from 6 to 12 years

Interventions

Arm 1 Intervention Name: VisionGuard Pro marine collagen nutritional jelly Type: Dietary supplement / nutritional product Dose &amp

regimen: 1 sachet (15 g) orally once daily for 12 weeks Packaging: Identical single-dose sachets

flavor/color matched to placebo Compliance: Sachet count and diary Concomitant restrictions: No myopia-control therapies (atropine, ortho-K, dual-focus lenses) during study Arm 2 Control Name: P

regimen: 1 sachet (15 g) orally once daily for 12 weeks Description: Identical appearance, texture, and taste

no active nutrients Compliance: Sachet count + diary Sample size Per arm: 40 participants

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Children aged from 6 to 12 years. Diagnosis of progressive myopia (0.50 D progression in the past 12 months or axial length increase more that 0.2 mm/year). Spherical equivalent refractive error between minus 1.00 D and minus 6.00 D at baseline. Best-corrected visual acuity of 20/25 (0.8 decimal) or better in each eye. General good health without systemic or ocular disease affecting visual development. Willingness of both participant and parent/guardian to provide informed consent and comply with study protocol.

Exclusion criteria

Exclusion criteria: Previous or current use of myopia control therapies (atropine, orthokeratology, specialized contact lenses). Ocular pathology other than myopia (e.g., amblyopia, strabismus, keratoconus, retinal disease). History of systemic disease that may affect vision (e.g., diabetes, connective tissue disorders). Known allergy or intolerance to any components of the investigational or placebo jelly. Participation in another interventional clinical trial within the past 3 months. Inability of participant or parent/guardian to comply with study procedures.

Design outcomes

Primary

Measure	Time frame
Change in axial length (mm), measured by optical biometry (e.g., IOLMaster or equivalent device), at baseline and 12 weeks.	—

Secondary

Measure	Time frame
Choroidal thickness, measured using enhanced depth imaging OCT, at baseline and 12 weeks. Macular pigment optical density (MPOD), assessed by heterochromatic flicker photometry or equivalent, at baseline and 12 weeks. Accommodation amplitude and facility, measured with standard optometric methods, at baseline and 12 weeks. Contrast sensitivity, evaluated using Pelli-Robson chart, at baseline and 12 weeks. Biomarkers: Serum levels of MMP-2, MMP-9, oxidative stress markers, and plasma concentrations of lutein, zeaxanthin, and DHA, at baseline and 12 weeks. Safety and tolerability: Incidence of adverse events (AEs), gastrointestinal tolerance, and adherence (compliance rate via dose-counting). Child acceptability/compliance, measured with standardized parental questionnaire and remaining product count.	—

Measure

Time frame

Choroidal thickness, measured using enhanced depth imaging OCT, at baseline and 12 weeks. Macular pigment optical density (MPOD), assessed by heterochromatic flicker photometry or equivalent, at baseline and 12 weeks. Accommodation amplitude and facility, measured with standard optometric methods, at baseline and 12 weeks. Contrast sensitivity, evaluated using Pelli-Robson chart, at baseline and 12 weeks. Biomarkers: Serum levels of MMP-2, MMP-9, oxidative stress markers, and plasma concentrations of lutein, zeaxanthin, and DHA, at baseline and 12 weeks. Safety and tolerability: Incidence of adverse events (AEs), gastrointestinal tolerance, and adherence (compliance rate via dose-counting). Child acceptability/compliance, measured with standardized parental questionnaire and remaining product count.

—

Countries

Asia(except Japan)

Contacts

Public ContactGuzel Bikbova

Fusion Inc Research and Develpment

gbikbova@fusion-edu.com08046316681

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026