NCT06563700

Brief Summary

This is a multi-center , prospective, randomised, longitudinal study to evaluate rate of myopia progression with novel lenses compared to Single-Vision spectacles. A total of 342 children will be recruited where 57 participants each are randomised to wear one of 5 test spectacle lens designs or a single vision lens (control) for 12 months. At the end of 12 months, those randomised to single vision lenses will be transferred to one of the test lenses and all the groups continued for another 12 months. Myopia progression during the second year with test lenses will be compared to historical or published controls.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
342

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Aug 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 Progress58%
Aug 2024Jul 2027

First Submitted

Initial submission to the registry

August 6, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

August 16, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 21, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

April 28, 2026

Status Verified

August 1, 2025

Enrollment Period

3 years

First QC Date

August 6, 2024

Last Update Submit

April 26, 2026

Conditions

Myopia, Progressive

Outcome Measures

Primary Outcomes (1)

  • myopia progression

    change in spherical equivalent from baseline for each of the groups of BD test lenses and the single vision control group

    12 monthly

Secondary Outcomes (2)

  • axial elongation

    12 monthly

  • Subjective responses and compliance

    12 monthly

Study Arms (6)

Group A

PLACEBO COMPARATOR

single vision lens

Other: spectacle lensOther: single vision lens

Group B

EXPERIMENTAL

one of ZEISS BD spectacle lens designs 1 to 5

Other: spectacle lens

Group C

EXPERIMENTAL

one of ZEISS BD spectacle lens designs 1 to 5

Other: spectacle lens

Group D

EXPERIMENTAL

one of ZEISS BD spectacle lens designs 1 to 5

Other: spectacle lens

Group E

EXPERIMENTAL

one of ZEISS BD spectacle lens designs 1 to 5

Other: spectacle lens

Group F

EXPERIMENTAL

one of ZEISS BD spectacle lens designs 1 to 5

Other: spectacle lens

Interventions

single vision lensOTHER

single vision lens

Group A
spectacle lensOTHER

one of ZEISS BD spectacle lens designs 1 to 5

Group AGroup BGroup CGroup DGroup EGroup F

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • be accompanied by a parent or guardian who is able to read and comprehend Chinese/English and sign a record of informed consent/assent; at baseline, be within the age range of 7 to 13 years old inclusive; be diagnosed as myopic having cycloplegic spherical equivalent between -0.75 dioptre (D) and -5.00 dioptre (D); astigmatism ≤1.50D; anisometropia of not more than 1.50D; be willing to comply with the wearing of clinical trial spectacles and clinical trial visit schedule as directed by the investigator; have ocular findings deemed to be normal; vision correctable to at least 0.8 or better in each eye with spectacles.

You may not qualify if:

  • Any pre-existing systemic or ocular condition, including infection or disease that is likely to affect visual acuity and refractive error; Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.
  • Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology in an adverse or beneficial manner at enrolment and/or during the clinical trial.
  • History of eye trauma Amblyopia Strabismus History of use of myopia control interventions such as Orthokeratology, atropine or eye surgery 6 months prior to commencement of this trial.
  • Known allergy or intolerance to ingredients to cycloplegic eye-drops. Currently enrolled in another clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, China

Location

MeSH Terms

Conditions

Myopia, Degenerative

Condition Hierarchy (Ancestors)

MyopiaRefractive ErrorsEye Diseases

Study Officials

  • Xiangui He

    Shanghai Eye Diseases Prevention and Treatment Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2024

First Posted

August 21, 2024

Study Start

August 16, 2024

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

April 28, 2026

Record last verified: 2025-08

Locations

CN(1)