MyopiaNCT07021560
Wearability of and Myopia Progression With ZEISS MyoCare Spectacle Lenses
A study testing ZEISS MyoCare spectacle lenses, ZEISS SV RX SPH 1.5 and ZEISS Clearview in people with Myopia, run by ZEISS Vision Care at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- ZEISS MyoCare spectacle lenses, ZEISS SV RX SPH 1.5 and ZEISS Clearview
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteVietnam
- Study dates
- 27 May 2025to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Hanoi Eye Hospital 2
Hanoi
Dr Chi, MD, 0825 769 777, Res-edu@mathanoi2.vn
About this study
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
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
- Being tested
- ZEISS MyoCare spectacle lenses, ZEISS SV RX SPH 1.5, ZEISS Clearview
- Keywords
- myopia
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZEISS MyoCare spectacle lensesDevice
Spectacle lenses with conventional power profile including myopia control design.
ZEISS SV RX SPH 1.5Device
Commercially available single vision
ZEISS ClearviewDevice
Commercially available single vision
| Study group | Role | What they receive |
|---|---|---|
| SV 1 | Active comparator | Single vision lenses Receives: Device: ZEISS SV RX SPH 1.5 |
| SV 2 | Active comparator | Single vision lenses Receives: Device: ZEISS Clearview |
| MyoCare | Experimental | ZEISS MyoCare spectacle lenses Receives: Device: ZEISS MyoCare spectacle lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wearability
Visual acuity with study spectacle lenses
Measured: 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
Measured: 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
Measured: At 1-week, 2-week, 3 months and 6 months visits
Secondary outcomes (2)
Myopia progression
The 6 monthly myopia progression measured by change in spherical equivalent from baseline for each of the study groups.
Measured: At baseline and 6 months visits
Myopia progression
The 6 monthly myopia progression measured by change in axial length from baseline for each of the study groups.
Measured: At baseline, 3 months, and 6 months visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start27 May 2025
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ZEISS Vision Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chi Hoang Viet Vu, MD, Principal investigator, Hanoi Eye Hospital 2
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021560
- Sponsor's protocol ID
- 28/CV-MHN2
- Status last verified
- Jun 2025
- First submitted
- 16 May 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07021560
- Acronym / sponsor ID
- 28/CV-MHN2
- Conditions
- Myopia
- Keywords
- myopia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- ZEISS Vision CareIndustry (pharma, biotech, devices)
- Study start
- 27 May 2025 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SV 1 | Active comparator | Device: ZEISS SV RX SPH 1.5Single vision lenses |
| SV 2 | Active comparator | Device: ZEISS ClearviewSingle vision lenses |
| MyoCare | Experimental | Device: ZEISS MyoCare spectacle lensesZEISS MyoCare spectacle lenses |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZEISS MyoCare spectacle lensesSpectacle lenses with conventional power profile including myopia control design. | Device | MyoCare |
| ZEISS SV RX SPH 1.5Commercially available single vision | Device | SV 1 |
| ZEISS ClearviewCommercially available single vision | Device | SV 2 |
Primary outcome
Wearability
Time frame: Day 1 At dispensing visit, 3 months and 6 months visits
Visual acuity with study spectacle lenses
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
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
2 secondary outcomes
Myopia progression
Time frame: At baseline and 6 months visits
Myopia progression
Time frame: At baseline, 3 months, and 6 months visits
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chi Hoang Viet Vu, MD principal investigator
Hanoi Eye Hospital 2
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ZEISS MyoCare spectacle lenses, ZEISS SV RX SPH 1.5 and ZEISS Clearview in people with Myopia, run by ZEISS Vision Care at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Liu, MBBS, MOptom, PhD (+61 413759820, xiao.liu@zeiss.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wearability (time frame: Day 1 At dispensing visit, 3 months and 6 months visits). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.