Wearability and myopia control with ZEISS MyoCare versus ZEISS single‑vision spectacle lenses

A Double Masked, Randomised, Longitudinal Comparative Study to Evaluate the Wearability and Myopia Progression of ZEISS MyoCare Spectacle Lenses Versus Two ZEISS Single Vision Spectacle Lenses in Children With Myopia

This test will see if ZEISS MyoCare spectacle lenses, compared with two ZEISS single‑vision lenses, slow myopia progression in children aged 7 to 13.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 7 Years to 13 Years
• Sex: All
• Sponsor: ZEISS Vision Care (Industry-sponsored)
• Locations: 1 site (Hanoi)
• Trial ID: NCT07021560 on ClinicalTrials.gov

What this trial studies

Children aged 7–13 with mild to moderate myopia are randomly assigned to wear one of three ZEISS spectacle lens types for six months. The protocol includes five in‑person clinic visits and two virtual follow‑ups to measure axial length, refractive error, and how well the lenses are worn. Eligible participants have cycloplegic spherical equivalent between −0.75 D and −5.00 D, astigmatism ≤1.50 D, anisometropia ≤1.50 D, and vision correctable to at least 0.8 in each eye. The trial is sponsored by ZEISS Vision Care and conducted at Hanoi Eye Hospital 2.

Who should consider this trial

Good fit: Ideal candidates are children 7–13 years old with myopia between −0.75 D and −5.00 D, astigmatism ≤1.50 D, anisometropia ≤1.50 D, vision correctable to at least 0.8, and a parent or guardian who can consent in Vietnamese or English.

Not a fit: Children with systemic or ocular diseases affecting vision, refractive errors outside the specified ranges, higher astigmatism, or who cannot comply with wearing the trial spectacles are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the ZEISS MyoCare lenses could slow axial elongation and reduce the rate of myopia progression in participating children.

How similar studies have performed: Other peripheral‑defocus and dual‑focus spectacle lens designs have produced modest reductions in myopia progression in multiple trials, though effectiveness varies by design and patient age.

Eligibility criteria

Inclusion Criteria:

* be accompanied by a parent or guardian who is able to read and comprehend Vietnamese/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.
* 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. NB: Systemic antihistamines are allowed on an "as needed basis", provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used.
* History of eye trauma or eye surgery
* Amblyopia
* Anisometropia of not more than 1.50D
* Strabismus
* History of use of myopia control interventions such as Orthokeratology or atropine 3 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

Hanoi

• Hanoi Eye Hospital 2 — Hanoi, Vietnam (Recruiting)

Study contacts

• Principal investigator: Chi Hoang Viet Vu, MD — Hanoi Eye Hospital 2
• Study coordinator: Nicole Liu, MBBS, MOptom, PhD

Conditions Myopia; myopia