Novel Lenses for Myopia Progression Trial

A Double Masked, Randomised, Longitudinal Comparative Study to Evaluate the Myopia Progression of Novel Spectacle Lenses Versus Single Vision Spectacle Lenses in Children With Myopia

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myopia, Progressive
• Intervention / Treatment: Other: spectacle lens; Other: single vision lens

• Study Type: Interventional
• Enrollment (Actual): 342
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Eye Disease Prevention and Treatment Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group A; single vision lens	Other: spectacle lens; one of ZEISS BD spectacle lens designs 1 to 5; Other: single vision lens; single vision lens
Experimental: Group B; one of ZEISS BD spectacle lens designs 1 to 5	Other: spectacle lens; one of ZEISS BD spectacle lens designs 1 to 5
Experimental: Group C; one of ZEISS BD spectacle lens designs 1 to 5	Other: spectacle lens; one of ZEISS BD spectacle lens designs 1 to 5
Experimental: Group D; one of ZEISS BD spectacle lens designs 1 to 5	Other: spectacle lens; one of ZEISS BD spectacle lens designs 1 to 5
Experimental: Group E; one of ZEISS BD spectacle lens designs 1 to 5	Other: spectacle lens; one of ZEISS BD spectacle lens designs 1 to 5
Experimental: Group F; one of ZEISS BD spectacle lens designs 1 to 5	Other: spectacle lens; one of ZEISS BD spectacle lens designs 1 to 5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
axial elongation	change in axial length from baseline for each of the groups of BD test lenses and the single vision control group	12 monthly
Subjective responses and compliance	Subjective visual responses of wearing spectacles and compliance using questionair for each groups	12 monthly

Collaborators and Investigators

• Sponsor: Shanghai Eye Disease Prevention and Treatment Center
• Investigators: Principal Investigator: Xiangui He, Shanghai Eye Diseases Prevention and Treatment Center

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: August 6, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 21, 2024

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 26, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Myopia, Degenerative
• Other Study ID Numbers: 2024-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No