Myopia, ProgressiveNCT06563700
Novel Lenses for Myopia Progression Trial
A study testing spectacle lens and single vision lens in people with Myopia, Progressive, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
This is a multi-center , prospective, randomised, longitudinal study to evaluate rate of myopia progression with novel lenses compared to Single-Vision spectacles. A total of 342 children will be recruited where 57 participants each are randomised to wear one of 5 test spectacle lens designs or a single vision lens… Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Myopia, Progressive
- What is being tested?
- spectacle lens and single vision lens
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 342 participants
- Where
- 1 siteChina
- Study dates
- 16 Aug 2024to 31 Jul 2027
- 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
- No healthy volunteers
- Child
Who may be able to join
- be accompanied by a parent or guardian who is able to read and comprehend Chinese/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. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.
- 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.
- History of eye trauma Amblyopia Strabismus History of use of myopia control interventions such as Orthokeratology, atropine or eye surgery 6 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.
About this study
Official title: A Double Masked, Randomised, Longitudinal Comparative Study to Evaluate the Myopia Progression of Novel Spectacle Lenses Versus Single Vision Spectacle Lenses in Children With Myopia
This is a multi-center , prospective, randomised, longitudinal study to evaluate rate of myopia progression with novel lenses compared to Single-Vision spectacles. A total of 342 children will be recruited where 57 participants each are randomised to wear one of 5 test spectacle lens designs or a single vision lens (control) for 12 months. At the end of 12 months, those randomised to single vision lenses will be transferred to one of the test lenses and all the groups continued for another 12 months. Myopia progression during the second year with test lenses will be compared to historical or published controls.
- Conditions
- Myopia, Progressive
- Being tested
- spectacle lens, single vision lens
- Medical subject headings
- Myopia, Degenerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spectacle lensOther
one of ZEISS BD spectacle lens designs 1 to 5
single vision lensOther
single vision lens
| Study group | Role | What they receive |
|---|---|---|
| Group A | Placebo comparator | single vision lens Receives: Other: spectacle lens; Other: single vision lens |
| Group B | Experimental | one of ZEISS BD spectacle lens designs 1 to 5 Receives: Other: spectacle lens |
| Group C | Experimental | one of ZEISS BD spectacle lens designs 1 to 5 Receives: Other: spectacle lens |
| Group D | Experimental | one of ZEISS BD spectacle lens designs 1 to 5 Receives: Other: spectacle lens |
| Group E | Experimental | one of ZEISS BD spectacle lens designs 1 to 5 Receives: Other: spectacle lens |
| Group F | Experimental | one of ZEISS BD spectacle lens designs 1 to 5 Receives: Other: spectacle lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
myopia progression
change in spherical equivalent from baseline for each of the groups of BD test lenses and the single vision control group
Measured: 12 monthly
Secondary outcomes (2)
axial elongation
change in axial length from baseline for each of the groups of BD test lenses and the single vision control group
Measured: 12 monthly
Subjective responses and compliance
Subjective visual responses of wearing spectacles and compliance using questionair for each groups
Measured: 12 monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start16 Aug 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia, ProgressiveStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiangui He, Principal investigator, Shanghai Eye Diseases Prevention and Treatment Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563700
- Sponsor's protocol ID
- 2024-002
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2024
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. 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 Myopia Progression of Novel Spectacle Lenses Versus Single Vision Spectacle Lenses in Children With Myopia
- ClinicalTrials.gov ID
- NCT06563700
- Acronym / sponsor ID
- 2024-002
- Conditions
- Myopia, Progressive
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 21 Aug 2024 (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 multi-center , prospective, randomised, longitudinal study to evaluate rate of myopia progression with novel lenses compared to Single-Vision spectacles. A total of 342 children will be recruited where 57 participants each are randomised to wear one of 5 test spectacle lens designs or a single vision lens (control) for 12 months. At the end of 12 months, those randomised to single vision lenses will be transferred to one of the test lenses and all the groups continued for another 12 months. Myopia progression during the second year with test lenses will be compared to historical or published controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Other: spectacle lens, Other: single vision lenssingle vision lens |
| Group B | Experimental | Other: spectacle lensone of ZEISS BD spectacle lens designs 1 to 5 |
| Group C | Experimental | Other: spectacle lensone of ZEISS BD spectacle lens designs 1 to 5 |
| Group D | Experimental | Other: spectacle lensone of ZEISS BD spectacle lens designs 1 to 5 |
| Group E | Experimental | Other: spectacle lensone of ZEISS BD spectacle lens designs 1 to 5 |
| Group F | Experimental | Other: spectacle lensone of ZEISS BD spectacle lens designs 1 to 5 |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- be accompanied by a parent or guardian who is able to read and comprehend Chinese/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.
Key exclusion criteria (4 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. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.
- 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.
- History of eye trauma Amblyopia Strabismus History of use of myopia control interventions such as Orthokeratology, atropine or eye surgery 6 months prior to commencement of this trial.
- Known allergy or intolerance to ingredients to cycloplegic eye-drops. Currently enrolled in another clinical trial.
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 |
|---|---|---|
| spectacle lensone of ZEISS BD spectacle lens designs 1 to 5 | Other | Group A, Group B, Group C, Group D, Group E, Group F |
| single vision lenssingle vision lens | Other | Group A |
Primary outcome
myopia progression
Time frame: 12 monthly
change in spherical equivalent from baseline for each of the groups of BD test lenses and the single vision control group
2 secondary outcomes
axial elongation
Time frame: 12 monthly
Subjective responses and compliance
Time frame: 12 monthly
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 28 Apr 2026.
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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. This study is not recruiting at the moment.
Xiangui He principal investigator
Shanghai Eye Diseases Prevention and Treatment Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spectacle lens and single vision lens in people with Myopia, Progressive, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
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 1 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. 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 China. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
myopia progression (time frame: 12 monthly). 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 28 Apr 2026.