Wearability of and Myopia Progression With ZEISS MyoCare Spectacle Lenses

NCT ID: NCT07021560

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-27
• Study Completion Date: 2026-01-31

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.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SV 1

Single vision lenses

Group Type: ACTIVE_COMPARATOR

ZEISS SV RX SPH 1.5

Intervention Type: DEVICE

Commercially available single vision

SV 2

Single vision lenses

Group Type: ACTIVE_COMPARATOR

ZEISS Clearview

Intervention Type: DEVICE

Commercially available single vision

MyoCare

ZEISS MyoCare spectacle lenses

Group Type: EXPERIMENTAL

ZEISS MyoCare spectacle lenses

Intervention Type: DEVICE

Spectacle lenses with conventional power profile including myopia control design.

Interventions

ZEISS MyoCare spectacle lenses

Spectacle lenses with conventional power profile including myopia control design.

Intervention Type: DEVICE

ZEISS SV RX SPH 1.5

Commercially available single vision

Intervention Type: DEVICE

ZEISS Clearview

Commercially available single vision

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ZEISS Vision Care

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chi Hoang Viet Vu, MD

Role: PRINCIPAL_INVESTIGATOR

Hanoi Eye Hospital 2

Locations

Hanoi Eye Hospital 2

Hanoi, , Vietnam

Site Status: RECRUITING

Countries

Vietnam

Central Contacts

Nicole Liu, MBBS, MOptom, PhD

Role: CONTACT

xiao.liu@zeiss.com

+61 413759820

Facility Contacts

Dr Chi, MD

Role: primary

Res-edu@mathanoi2.vn

0825 769 777

Other Identifiers

28/CV-MHN2

Identifier Type: -

Identifier Source: org_study_id