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NCT Number: NCT07021560

Wearability of and Myopia Progression With ZEISS MyoCare Spectacle Lenses

This is a clinical trial evaluating the wearability and effectiveness of three types of ZEISS spectacle lenses in controlling myopia progression. This study compares ZEISS MyoCare spectacle lenses with two types of single-vision spectacle lenses over a 6-month period. This trial aims to evaluate how well these lenses are worn and their impact on myopia progression, including changes in axial length and refractive error.

Participants will be randomly assigned to wear one of three types of ZEISS spectacle lenses. The study will require five visits to the eye clinic over a 6-month period and two virtual follow-up visits.

Recruiting

Interested in participating?

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Key information

Age range

7 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

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 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.

Treatment and study plan

ZEISS MyoCare spectacle lenses

Device

Spectacle lenses with conventional power profile including myopia control design.

ZEISS SV RX SPH 1.5

Device

Commercially available single vision

ZEISS Clearview

Device

Commercially available single vision

Primary outcomes

  1. Wearability

    Time frame: Day 1 At dispensing visit, 3 months and 6 months visits

    Visual acuity with study spectacle lenses

  2. Wearability

    Time frame: Day 1 At dispensing visit, 1-week and 2-week visits, and 3 months and 6 months visits

    Subjective responses measured by a wearability questionnaire (scale 1-10, with 1 being the worst and 10 being the best) regarding study spectacle lenses wear

  3. Wearability

    Time frame: At 1-week, 2-week, 3 months and 6 months visits

    Compliance (lens wearing time, hr/day) to study spectacle lenses wear

Secondary outcomes

  1. Myopia progression

    Time frame: At baseline and 6 months visits

    The 6 monthly myopia progression measured by change in spherical equivalent from baseline for each of the study groups.

  2. Myopia progression

    Time frame: At baseline, 3 months, and 6 months visits

    The 6 monthly myopia progression measured by change in axial length from baseline for each of the study groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Nicole Liu, MBBS, MOptom, PhD

CONTACT

[email protected]

+61 413759820

Sponsors and collaborators

Lead sponsor

ZEISS Vision Care

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 15, 2025
Registry last updated
Jun 15, 2025

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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