NCT06647160

Brief Summary

The goal of this randomised controlled clinical trial is to compare the effects of a new type of concentric columnar microstructure lens and single-vision spectacle lenses on myopia progression in Chinese children aged 8-11 years with refractive error ranging from -0.50D to -6.00D. Participants will wear spectacles and receive follow-up examinations every half year.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress63%
Nov 2024Mar 2027

First Submitted

Initial submission to the registry

October 14, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2024

Completed
15 days until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2027

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

2.2 years

First QC Date

October 14, 2024

Last Update Submit

March 11, 2026

Conditions

Myopia, Progressive

Keywords

concentric columnar microstructureMyopia control

Outcome Measures

Primary Outcomes (1)

  • Changes of spherical equivalent refraction (SER) at two years

    The difference of SER (Diopter) at two years compared with baseline SER. SER will be measured after cycloplegia.

    2 years

Secondary Outcomes (3)

  • Changes of axial length (AL) at two years

    2 years

  • Visual scale score at two years

    2 years

  • Incidence of adverse event during study period

    2 years

Other Outcomes (5)

  • Change of lens thickness (LT) at two years

    2 years

  • Change of corneal power (CP) at two years

    2 years

  • Best corrected visual acuity at two years

    2 years

  • +2 more other outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Blue star MAX-5 spectacle lens

Device: Blue star MAX-5 spectacle lens

Control

ACTIVE COMPARATOR

Single-vision spectacle lens

Device: Single-vision spectacle lens

Interventions

Blue star MAX-5 spectacle lensDEVICE

The children in the experimental group will wear Blue star MAX-5 spectacle lens and receive follow-up examinations every half year.

Intervention
Single-vision spectacle lensDEVICE

The children in the single-vision lenses group will wear single-vision spectacle lens and receive follow-up examinations every half year.

Control

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Aged 8 to 11 years;
  • Under the condition of bilateral cycloplegic autorefraction, the spherical refractive error of -6.00 to -0.50 D in each eye and astigmatism of not more than 1.50 D and anisometropia of not more than 1.50 D;
  • Best-corrected visual acuity of equal or better than 0.00 LogMAR (\>= 1.0 as Snellen).
  • The intraocular pressure of 10 to 21mmHg.
  • Volunteer to participate in this clinical trial with signature of the informed consent form.

You may not qualify if:

  • History of eye injury or intraocular surgery;
  • Clinically abnormal slit-lamp findings
  • Abnormal fundus examination
  • Ocular disease, such as uveitis and other inflammatory diseases, glaucoma, cataract, fundus diseases, eye tumors, dominant strabismus, and any eye diseases that affect visual function;
  • Systemic diseases causing low immunity (such as diabetes, Down's syndrome, rheumatoid arthritis, psychotic patients or other diseases that researchers think are not suitable for wearing glasses);
  • Participation of the drug clinical trial within three month and the device clinical trial within one month;
  • Unable to have regular follow-up
  • Participation of any myopia control clinical research trial within three months, and currently using rigid contact lenses (including nursingproducts), multifocal contact lenses, progressive multifocal lenses and other specially designed myopia control lenses, atropine drugs, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Myopia, Degenerative

Condition Hierarchy (Ancestors)

MyopiaRefractive ErrorsEye Diseases

Study Officials

  • Jian Ge

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2024

First Posted

October 17, 2024

Study Start

November 1, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

March 30, 2027

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations

CN(1)