MyopiaNCT07846787
Control of Myopia in Young Children Using H.O.P.E. Lenses Combined With 0.02% Atropine Eye Drops
A study testing High-order Phase Element Array Microstructure Design Lens (H.O.P.E.) and 0.02% Atropine Sulfate Eye Drops in people with Myopia, run by Ruihua Wei at 1 site in China.
Trial summary
A multicenter, prospective, intervention study on the control of myopia in young children using high-order phase element array microstructure lenses (H.O.P.E.) in combination with low-concentration atropine eye drops (0.02%) Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Myopia
- What is being tested?
- High-order Phase Element Array Microstructure Design Lens (H.O.P.E.) and 0.02% Atropine Sulfate Eye Drops
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2026to 20 Sep 2028
- 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 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 6-9 years old (6 years old but under 10 years old), gender not restricted;
- Clinically diagnosed with bilateral myopia (after cycloplegia), refractive error within -6.00D < SER ≤ -0.50D, astigmatism ≤ 1.50D, refractive anisometropia ≤ 1.50D (based on subjective refraction values);
- Corrected visual acuity LogMAR ≤ 0.1;
- Able to understand the research purpose, voluntarily participate, and the subject and his/her legal guardian sign the informed consent form.
Who cannot join
- If a subject meets any of the following exclusion criteria, they will not be included in this study:
- Those who have discontinued the use of atropine eye drops (due to glaucoma or a tendency towards glaucoma, or are allergic to scopolamine or the components of this product);
- Those currently suffering from any of the following diseases that may affect vision or refractive errors, or ocular organic diseases: such as diseases causing damage to the lens like cataracts, glaucoma, macular degeneration, corneal diseases, uveitis, retinal detachment, severe vitreous opacity, acute/chronic keratitis, conjunctivitis, irregular cornea, keratoconus, manifest strabismus, fundus diseases, etc.; systemic diseases that may affect the eyes, such as immune system diseases, central nervous system diseases, Down syndrome, asthma, epilepsy, severe heart or lung function disorders, severe liver or kidney function impairments, etc.;
- Those who have participated in other clinical trials or studies related to myopia control within 90 days before signing the informed consent form;
- Those who have used myopia control products within 90 days before signing the informed consent form (such as near-axial lenses, low-concentration atropine eye drops, corneal reshaping lenses, red light, etc.);
- Those who cannot wear glasses regularly or use the medication as required (such as having a significant difference in compliance);
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- During the screening period, the intraocular pressure of either eye is greater than 21 mmHg or less than 10 mmHg, or the intraocular pressure difference between both eyes is ≥ 5 mmHg;
- There is a severe abnormality in the accommodative function (accommodative amplitude < 8D);
- Only one eye meets the inclusion criteria;
- Other situations that the researcher deems unsuitable for participating in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tianjin Medical University Eye Hospital
Tianjin
Meinan He, 13672135765, hmn509@tmu.edu.cn
About this study
Official title: A Multicenter, Prospective, Intervention Study on the Control of Myopia in Young Children Using High-order Phase Element Array Microstructure Lenses (H.O.P.E.) in Combination With Low-concentration Atropine Eye Drops (0.02%)
A multicenter, prospective, intervention study on the control of myopia in young children using high-order phase element array microstructure lenses (H.O.P.E.) in combination with low-concentration atropine eye drops (0.02%)
Read the detailed description
This study focused on 6-9-year-old young children as the research subjects, aiming to investigate 1. The effectiveness of using H.O.P.E. lenses alone and in combination with 0.02% atropine eye drops, in order to provide data support and clinical guidance for the clinical effectiveness and safety of the high-order phase unit (H.O.P.E.) array microstructure lenses in young children with myopia.
- Conditions
- Myopia
- Being tested
- High-order Phase Element Array Microstructure Design Lens (H.O.P.E.), 0.02% Atropine Sulfate Eye Drops
- 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.
High-order Phase Element Array Microstructure Design Lens (H.O.P.E.)Device
Wear the H.O.P.E. lens frame glasses and use the placebo. Use it once per night for both eyes.
0.02% Atropine Sulfate Eye DropsDrug
Wear single-vision frame glasses and use 0.02% atropine sulfate eye drops twice a day, once at night for both eyes.
| Study group | Role | What they receive |
|---|---|---|
| Group A (H.O.P.E. Lens Group) | Active comparator | Wearing H.O.P.E. lens frame glasses (provided by Shenyang Kangnd Medical Technology Co., Ltd.) Receives: Device: High-order Phase Element Array Microstructure Design Lens (H.O.P.E.) |
| Group B (0.02% Atropine group) | Active comparator | Use 0.02% atropine sulfate eye drops (provided by Shenyang Xingqi Eye Pharmaceuticals Co., Ltd.) Receives: Drug: 0.02% Atropine Sulfate Eye Drops |
| Group C (H.O.P.E. lenses + 0.02% atropine group) | Experimental | Wearing H.O.P.E. lens frame glasses (provided by Shenyang Kangnd Medical Technology Co., Ltd.); Use 0.02% atropine sulfate eye drops (provided by Shenyang Xingqi Eye Pharmaceuticals Co., Ltd.) Receives: Device: High-order Phase Element Array Microstructure Design Lens (H.O.P.E.); Drug: 0.02% Atropine Sulfate Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
The final spherical equivalent refractive error (SER) measured by cycloplegic refraction combined with both automated and subjective refraction after 12 months of wearing glasses, compared with the baseline value.
Measured: From enrollment to the end of treatment at 12 months
Secondary outcomes (1)
The change in AL (axial length) from the baseline after wearing the glasses for 12 months
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion19 Aug 2028 (estimated)
- Study completion20 Sep 2028 (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
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruihua Wei
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Medical University Eye Hospital
- Responsible party
- Sponsor-investigator, Ruihua Wei, Tianjin Medical University Eye Hospital
- Investigators
- Ruihua Wei, Principal investigator, Tianjin Medical University Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846787
- Sponsor's protocol ID
- KCAK260A2026001
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 29 Sep 2026
- 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 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Intervention Study on the Control of Myopia in Young Children Using High-order Phase Element Array Microstructure Lenses (H.O.P.E.) in Combination With Low-concentration Atropine Eye Drops (0.02%)
- ClinicalTrials.gov ID
- NCT07846787
- Acronym / sponsor ID
- KCAK260A2026001
- Conditions
- Myopia
- Keywords
- myopia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Ruihua WeiUniversity, hospital or other
- Collaborators
- Tianjin Medical University Eye Hospital
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 19 Aug 2028 (estimated)
- Study completion
- 20 Sep 2028 (estimated)
- First posted
- 29 Sep 2026 (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.
A multicenter, prospective, intervention study on the control of myopia in young children using high-order phase element array microstructure lenses (H.O.P.E.) in combination with low-concentration atropine eye drops (0.02%)
Detailed description
This study focused on 6-9-year-old young children as the research subjects, aiming to investigate 1. The effectiveness of using H.O.P.E. lenses alone and in combination with 0.02% atropine eye drops, in order to provide data support and clinical guidance for the clinical effectiveness and safety of the high-order phase unit (H.O.P.E.) array microstructure lenses in young children with myopia.
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 |
|---|---|---|
| Group A (H.O.P.E. Lens Group) | Active comparator | Device: High-order Phase Element Array Microstructure Design Lens (H.O.P.E.)Wearing H.O.P.E. lens frame glasses (provided by Shenyang Kangnd Medical Technology Co., Ltd.) |
| Group B (0.02% Atropine group) | Active comparator | Drug: 0.02% Atropine Sulfate Eye DropsUse 0.02% atropine sulfate eye drops (provided by Shenyang Xingqi Eye Pharmaceuticals Co., Ltd.) |
| Group C (H.O.P.E. lenses + 0.02% atropine group) | Experimental | Device: High-order Phase Element Array Microstructure Design Lens (H.O.P.E.), Drug: 0.02% Atropine Sulfate Eye DropsWearing H.O.P.E. lens frame glasses (provided by Shenyang Kangnd Medical Technology Co., Ltd.); Use 0.02% atropine sulfate eye drops (provided by Shenyang Xingqi Eye Pharmaceuticals Co., Ltd.) |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age: 6-9 years old (6 years old but under 10 years old), gender not restricted;
- Clinically diagnosed with bilateral myopia (after cycloplegia), refractive error within -6.00D < SER ≤ -0.50D, astigmatism ≤ 1.50D, refractive anisometropia ≤ 1.50D (based on subjective refraction values);
- Corrected visual acuity LogMAR ≤ 0.1;
- Able to understand the research purpose, voluntarily participate, and the subject and his/her legal guardian sign the informed consent form.
Key exclusion criteria (10 listed)
- If a subject meets any of the following exclusion criteria, they will not be included in this study:
- Those who have discontinued the use of atropine eye drops (due to glaucoma or a tendency towards glaucoma, or are allergic to scopolamine or the components of this product);
- Those currently suffering from any of the following diseases that may affect vision or refractive errors, or ocular organic diseases: such as diseases causing damage to the lens like cataracts, glaucoma, macular degeneration, corneal diseases, uveitis, retinal detachment, severe vitreous opacity, acute/chronic keratitis, conjunctivitis, irregular cornea, keratoconus, manifest strabismus, fundus diseases, etc.; systemic diseases that may affect the eyes, such as immune system diseases, central nervous system diseases, Down syndrome, asthma, epilepsy, severe heart or lung function disorders, severe liver or kidney function impairments, etc.;
- Those who have participated in other clinical trials or studies related to myopia control within 90 days before signing the informed consent form;
- Those who have used myopia control products within 90 days before signing the informed consent form (such as near-axial lenses, low-concentration atropine eye drops, corneal reshaping lenses, red light, etc.);
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 |
|---|---|---|
| High-order Phase Element Array Microstructure Design Lens (H.O.P.E.)Wear the H.O.P.E. lens frame glasses and use the placebo. Use it once per night for both eyes. | Device | Group A (H.O.P.E. Lens Group), Group C (H.O.P.E. lenses + 0.02% atropine group) |
| 0.02% Atropine Sulfate Eye DropsWear single-vision frame glasses and use 0.02% atropine sulfate eye drops twice a day, once at night for both eyes. | Drug | Group B (0.02% Atropine group), Group C (H.O.P.E. lenses + 0.02% atropine group) |
Primary outcome
The final spherical equivalent refractive error (SER) measured by cycloplegic refraction combined with both automated and subjective refraction after 12 months of wearing glasses, compared with the baseline value.
Time frame: From enrollment to the end of treatment at 12 months
1 secondary outcome
The change in AL (axial length) from the baseline after wearing the glasses for 12 months
Time frame: From enrollment to the end of treatment at 12 months
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 29 Sep 2026.
- 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.
Ruihua Wei principal investigator
Tianjin Medical University Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-order Phase Element Array Microstructure Design Lens (H.O.P.E.) and 0.02% Atropine Sulfate Eye Drops in people with Myopia, run by Ruihua Wei 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 4 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: opening soon, as of the sponsor's last update on 29 Sep 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?
Contact Meinan He (13672135765, hmn509@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The final spherical equivalent refractive error (SER) measured by cycloplegic refraction combined with both automated and subjective refraction after 12 months of wearing glasses, compared with the baseline value. (time frame: From enrollment to the end of treatment at 12 months). 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 29 Sep 2026.