Novel Lenses for Myopia Progression Trial

NCT ID: NCT06563700

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-16
• Study Completion Date: 2027-07-31

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.

Conditions

Myopia, Progressive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A

single vision lens

Group Type: PLACEBO_COMPARATOR

spectacle lens

Intervention Type: OTHER

one of ZEISS BD spectacle lens designs 1 to 5

single vision lens

Intervention Type: OTHER

single vision lens

Group B

one of ZEISS BD spectacle lens designs 1 to 5

Group Type: EXPERIMENTAL

spectacle lens

Intervention Type: OTHER

one of ZEISS BD spectacle lens designs 1 to 5

Group C

one of ZEISS BD spectacle lens designs 1 to 5

Group Type: EXPERIMENTAL

spectacle lens

Intervention Type: OTHER

one of ZEISS BD spectacle lens designs 1 to 5

Group D

one of ZEISS BD spectacle lens designs 1 to 5

Group Type: EXPERIMENTAL

spectacle lens

Intervention Type: OTHER

one of ZEISS BD spectacle lens designs 1 to 5

Group E

one of ZEISS BD spectacle lens designs 1 to 5

Group Type: EXPERIMENTAL

spectacle lens

Intervention Type: OTHER

one of ZEISS BD spectacle lens designs 1 to 5

Group F

one of ZEISS BD spectacle lens designs 1 to 5

Group Type: EXPERIMENTAL

spectacle lens

Intervention Type: OTHER

one of ZEISS BD spectacle lens designs 1 to 5

Interventions

spectacle lens

one of ZEISS BD spectacle lens designs 1 to 5

Intervention Type: OTHER

single vision lens

single vision lens

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Eye Disease Prevention and Treatment Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiangui He

Role: PRINCIPAL_INVESTIGATOR

Shanghai Eye Diseases Prevention and Treatment Center

Locations

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, , China

Countries

China

Other Identifiers

2024-002

Identifier Type: -

Identifier Source: org_study_id