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OpenTrials
Active, Not Recruiting

NCT Number: NCT06563700

Novel Lenses for Myopia Progression Trial

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

7 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

spectacle lens

Other

one of ZEISS BD spectacle lens designs 1 to 5

single vision lens

Other

single vision lens

Primary outcomes

  1. myopia progression

    Time frame: 12 monthly

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

Secondary outcomes

  1. axial elongation

    Time frame: 12 monthly

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

  2. Subjective responses and compliance

    Time frame: 12 monthly

    Subjective visual responses of wearing spectacles and compliance using questionair for each groups

Sponsors and collaborators

Lead sponsor

Shanghai Eye Disease Prevention and Treatment Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 21, 2024
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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