Clinical trial NCT07021560: Wearability of and Myopia Progression With ZEISS MyoCare Spectacle Lenses
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Keywords: myopia
Lead sponsor: ZEISS Vision Care
Sponsor class: INDUSTRY
First posted: 2025-06-15
Enrollment: 90
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Wearability
timeFrame: Day 1 At dispensing visit, 3 months and 6 months visits
measure: Wearability
timeFrame: Day 1 At dispensing visit, 1-week and 2-week visits, and 3 months and 6 months visits
measure: Wearability
timeFrame: At 1-week, 2-week, 3 months and 6 months visits
Secondary outcomes:
measure: Myopia progression
timeFrame: At baseline and 6 months visits
measure: Myopia progression
timeFrame: At baseline, 3 months, and 6 months visits
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Hanoi Eye Hospital 2
Study officials:
affiliation: Hanoi Eye Hospital 2
name: Chi Hoang Viet Vu, MD
role: PRINCIPAL_INVESTIGATOR
References: