Myopia, ProgressiveNCT06647160
Safety and Efficacy of Blue Star MAX-5 Lenses in Myopia Control
A study testing Blue star MAX-5 spectacle lens and Single-vision spectacle lens in people with Myopia, Progressive, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
The goal of this randomised controlled clinical trial is to compare the effects of a new type of concentric columnar microstructure lens and single-vision spectacle lenses on myopia progression in Chinese children aged 8-11 years with refractive error ranging from -0.50D to -6.00D. Read more about this study
- Who is it for?
- Ages 8 to 11 years
- Conditions the study is for
- Myopia, Progressive
- What is being tested?
- Blue star MAX-5 spectacle lens and Single-vision spectacle lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 30 Mar 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 8 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 8 to 11 years;
- Under the condition of bilateral cycloplegic autorefraction, the spherical refractive error of -6.00 to -0.50 D in each eye and astigmatism of not more than 1.50 D and anisometropia of not more than 1.50 D;
- Best-corrected visual acuity of equal or better than 0.00 LogMAR (>= 1.0 as Snellen).
- The intraocular pressure of 10 to 21mmHg.
- Volunteer to participate in this clinical trial with signature of the informed consent form.
Who cannot join
- History of eye injury or intraocular surgery;
- Clinically abnormal slit-lamp findings
- Abnormal fundus examination
- Ocular disease, such as uveitis and other inflammatory diseases, glaucoma, cataract, fundus diseases, eye tumors, dominant strabismus, and any eye diseases that affect visual function;
- Systemic diseases causing low immunity (such as diabetes, Down's syndrome, rheumatoid arthritis, psychotic patients or other diseases that researchers think are not suitable for wearing glasses);
- Participation of the drug clinical trial within three month and the device clinical trial within one month;
Show all 9Show fewer
- Only one eye meets the inclusion criteria;
- Unable to have regular follow-up
- Participation of any myopia control clinical research trial within three months, and currently using rigid contact lenses (including nursingproducts), multifocal contact lenses, progressive multifocal lenses and other specially designed myopia control lenses, atropine drugs, etc.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
Official title: Safety and Efficacy of Blue Star MAX-5 Lenses in Mvopia Control: A Randomized Controlled Clinical Trial
The goal of this randomised controlled clinical trial is to compare the effects of a new type of concentric columnar microstructure lens and single-vision spectacle lenses on myopia progression in Chinese children aged 8-11 years with refractive error ranging from -0.50D to -6.00D. Participants will wear spectacles and receive follow-up examinations every half year.
- Conditions
- Myopia, Progressive
- Being tested
- Blue star MAX-5 spectacle lens, Single-vision spectacle lens
- Keywords
- concentric columnar microstructure, Myopia control
- Medical subject headings
- Myopia, Degenerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue star MAX-5 spectacle lensDevice
The children in the experimental group will wear Blue star MAX-5 spectacle lens and receive follow-up examinations every half year.
Single-vision spectacle lensDevice
The children in the single-vision lenses group will wear single-vision spectacle lens and receive follow-up examinations every half year.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Blue star MAX-5 spectacle lens Receives: Device: Blue star MAX-5 spectacle lens |
| Control | Active comparator | Single-vision spectacle lens Receives: Device: Single-vision spectacle lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of spherical equivalent refraction (SER) at two years
The difference of SER (Diopter) at two years compared with baseline SER. SER will be measured after cycloplegia.
Measured: 2 years
Secondary outcomes (3)
Changes of axial length (AL) at two years
The difference of AL (mm) at two years compared with baseline AL. AL will be measured by IOLMaster-700.
Measured: 2 years
Visual scale score at two years
Visual scale score measured by the Chinese version of the pediatric refractive error profile2 (PREP2) is scaled from 0 (poor quality of life) to 100 (good quality of life).
Measured: 2 years
Incidence of adverse event during study period
Adverse event is a comprehensive qualitative outcome measure that will be evaluated based on the participants' symptoms and signs, intraocular pressure, slit lamp and fundus examinations, as well as lens and frame damage. The evaluation will be conducted every six months according to the predetermined definition of abnormalities in the above examinations.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start1 Nov 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Mar 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.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Ge, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647160
- Sponsor's protocol ID
- 2024KYPJ115
- Status last verified
- Mar 2026
- First submitted
- 14 Oct 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Blue Star MAX-5 Lenses in Mvopia Control: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06647160
- Acronym / sponsor ID
- 2024KYPJ115
- Conditions
- Myopia, Progressive
- Keywords
- concentric columnar microstructure, Myopia control
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 17 Oct 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.
The goal of this randomised controlled clinical trial is to compare the effects of a new type of concentric columnar microstructure lens and single-vision spectacle lenses on myopia progression in Chinese children aged 8-11 years with refractive error ranging from -0.50D to -6.00D. Participants will wear spectacles and receive follow-up examinations every half year.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Blue star MAX-5 spectacle lensBlue star MAX-5 spectacle lens |
| Control | Active comparator | Device: Single-vision spectacle lensSingle-vision spectacle lens |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged 8 to 11 years;
- Under the condition of bilateral cycloplegic autorefraction, the spherical refractive error of -6.00 to -0.50 D in each eye and astigmatism of not more than 1.50 D and anisometropia of not more than 1.50 D;
- Best-corrected visual acuity of equal or better than 0.00 LogMAR (>= 1.0 as Snellen).
- The intraocular pressure of 10 to 21mmHg.
- Volunteer to participate in this clinical trial with signature of the informed consent form.
Key exclusion criteria (9 listed)
- History of eye injury or intraocular surgery;
- Clinically abnormal slit-lamp findings
- Abnormal fundus examination
- Ocular disease, such as uveitis and other inflammatory diseases, glaucoma, cataract, fundus diseases, eye tumors, dominant strabismus, and any eye diseases that affect visual function;
- Systemic diseases causing low immunity (such as diabetes, Down's syndrome, rheumatoid arthritis, psychotic patients or other diseases that researchers think are not suitable for wearing glasses);
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 |
|---|---|---|
| Blue star MAX-5 spectacle lensThe children in the experimental group will wear Blue star MAX-5 spectacle lens and receive follow-up examinations every half year. | Device | Intervention |
| Single-vision spectacle lensThe children in the single-vision lenses group will wear single-vision spectacle lens and receive follow-up examinations every half year. | Device | Control |
Primary outcome
Changes of spherical equivalent refraction (SER) at two years
Time frame: 2 years
The difference of SER (Diopter) at two years compared with baseline SER. SER will be measured after cycloplegia.
3 secondary outcomes
Changes of axial length (AL) at two years
Time frame: 2 years
Visual scale score at two years
Time frame: 2 years
Incidence of adverse event during study period
Time frame: 2 years
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 12 Mar 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.
Jian Ge principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blue star MAX-5 spectacle lens and Single-vision spectacle lens in people with Myopia, Progressive, run by Zhongshan Ophthalmic Center, Sun Yat-sen University 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 5 inclusion and 9 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 12 Mar 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. 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?
Changes of spherical equivalent refraction (SER) at two years (time frame: 2 years). 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 12 Mar 2026.