Wearability of and Myopia Progression With ZEISS MyoCare Spectacle Lenses

NCT07021560 | Recruiting

• 1 other identifier: 28/CV-MHN2
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

myopia

Outcome Measures

Primary Outcomes (3)

• Wearability

  Visual acuity with study spectacle lenses

  Day 1 At dispensing visit, 3 months and 6 months visits

• Wearability

  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

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

• Wearability

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

  At 1-week, 2-week, 3 months and 6 months visits

Secondary Outcomes (2)

• Myopia progression

  At baseline and 6 months visits

• Myopia progression

  At baseline, 3 months, and 6 months visits

Study Arms (3)

SV 1

ACTIVE COMPARATOR

Single vision lenses

Device: ZEISS SV RX SPH 1.5

SV 2

ACTIVE COMPARATOR

Single vision lenses

Device: ZEISS Clearview

MyoCare

EXPERIMENTAL

ZEISS MyoCare spectacle lenses

Device: ZEISS MyoCare spectacle lenses

Interventions

ZEISS MyoCare spectacle lenses DEVICE

Spectacle lenses with conventional power profile including myopia control design.

MyoCare

ZEISS SV RX SPH 1.5 DEVICE

Commercially available single vision

SV 1

ZEISS Clearview DEVICE

Commercially available single vision

SV 2

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ZEISS Vision Care: lead

Study Sites (1)

Hanoi Eye Hospital 2

Hanoi, Vietnam

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Chi Hoang Viet Vu, MD

  Hanoi Eye Hospital 2

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Liu, MBBS, MOptom, PhD

CONTACT

+61 413759820; xiao.liu@zeiss.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: June 15, 2025
• Study Start: May 27, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)