Evaluating new lenses for controlling myopia in children

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 study is testing new types of glasses to see if they can help slow down worsening eyesight in children aged 7 to 13.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 7 Years to 13 Years
• Sex: All
• Sponsor: Shanghai Eye Disease Prevention and Treatment Center (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT06563700 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multi-center, prospective, randomized, longitudinal study aimed at assessing the effectiveness of novel spectacle lenses in slowing myopia progression in children aged 7 to 13. A total of 342 participants will be randomly assigned to wear one of five different lens designs or a standard single-vision lens for 12 months. After this period, those wearing single-vision lenses will switch to one of the test lenses for an additional year, allowing for a comparison of myopia progression rates between the groups. The study will utilize historical controls to evaluate the outcomes of the test lenses.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 7 to 13 years diagnosed with myopia, having a spherical equivalent between -0.75D and -5.00D.

Not a fit: Patients with pre-existing ocular or systemic conditions that could affect visual acuity or refractive error may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new method for effectively managing myopia progression in children, potentially reducing the risk of severe vision impairment later in life.

How similar studies have performed: Other studies have shown promise in using innovative lens designs to manage myopia, suggesting that this approach may be effective.

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.

Where this trial is running

Shanghai

• Shanghai Eye Disease Prevention and Treatment Center — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Xiangui He — Shanghai Eye Diseases Prevention and Treatment Center
• Study coordinator: Xiangui He

Conditions Myopia, Progressive