MyopiaNCT06034379
Electronic Spectacles Versus Low Dose Atropine in Young Myopes
A study testing eSpectacle Clinical prototype (CP1) device and 0.01% atropine in people with Myopia, run by Kubota Vision Inc. at 1 site in Taiwan.
Trial summary
This is a bilateral, dispensing, masked, randomized clinical trial. Myopic children will be randomly assigned to one of the following: (1) Investigational clinical prototype (CP1) device without atropine, (2) Investigational CP1 device with daily instillation of 0.01% atropine, or (3) daily instillation of 0.01%… Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- eSpectacle Clinical prototype (CP1) device and 0.01% atropine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2023to Dec 2025
- 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 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The subject must be between 6 and 13 years of age (inclusive).
- The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol.
- The guardian of a minor under 18 years old must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form. The subject under 18 years old must be willing to assent to the STATEMENT OF INFORMED CONSENT.
- Spherical component of refraction in the range of -0.50 to -10.00 DS in each eye.
- Refractive cylinder less than or equal to 2.00 DC in each eye (minus cylinder format).
- Best corrected distance VA of at least 20/25 in each eye.
Who cannot join
- Currently pregnant or lactating
- History of severe dry eye, strabismus, or amblyopia
- Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g., diabetes, rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with the participation in the study at the investigator's discretion.
- Use of systemic or ocular medications (e.g., chronic steroid use) that are known to interfere with vision and ocular accommodation at the investigator's discretion.
- Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, strabismus surgery etc.) or orthokeratology
- Any active ocular infection.
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- Any accommodative or binocular anomalies including amblyopia.
- Any physical or mental developmental delay.
- Any relevant ocular or systemic condition deemed unacceptable by the investigator that may negatively impact the subject's performance or ability to successfully complete the study (at the investigator's discretion)
- Anisometropia greater than 1.50D
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
CMU Hsinchu Hospital
Hsinchu
Wei-Hua Chen, 886 3 558 0558
About this study
Official title: Kubota Corrective Spectacles and Low Dose Atropine for Slowing Myopic Progression in Taiwanese Children
This is a bilateral, dispensing, masked, randomized clinical trial. Myopic children will be randomly assigned to one of the following: (1) Investigational clinical prototype (CP1) device without atropine, (2) Investigational CP1 device with daily instillation of 0.01% atropine, or (3) daily instillation of 0.01% atropine without use of the investigational CP1 device. Primary endpoint: Difference in the 12-month change of cycloplegic spherical refractive error and axial length between each of the three treatment groups.
Read the detailed description
The eSpectacle clinical prototype (CP1) device consists of a clear 15° central aperture and projects +9.00D defocused micro-LED lights onto the peripheral retina. In this pilot investigation, we aim to observe the ocular biometric and refractive changes following part-time wear of the clinical prototype device over a course of 12 months.
This trial is bilateral, dispensing, masked, and randomized (stratified by age). Myopic children will be randomly assigned to one of the following: (1) CP1 device without atropine, (2) CP1 device with daily instillation of 0.01% atropine, or (3) daily instillation of 0.01% atropine without use of the CP1 device.
A total of 45 subjects (15 per subgroup) are targeted to complete the study, which will consist of 8 visits: Screening, baseline/dispense, 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months. Subjects will be enrolled from the patient population at the investigator site.
The primary objective is to evaluate the effectiveness of the eSpectacle clinical prototype device with and without the use of 0.01 percent atropine for slowing the progression of myopia in Taiwanese children, by assessing changes in central axial length and cycloplegic autorefraction following at least 12 hours per week of wear over 12 months. To minimize bias, the primary outcome variables of cycloplegic autorefraction and axial length will be measured by a Masked Investigator.
- Conditions
- Myopia
- Being tested
- eSpectacle Clinical prototype (CP1) device, 0.01% atropine
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eSpectacle Clinical prototype (CP1) deviceDevice
The CP1 device consists of a clear 15° central aperture and projects +9.00D defocused micro-LED lights of approximately 4800 nits illumination to the peripheral retina.
0.01% atropineDrug
Atropine is a and anticholinergic medication which can be used for dilation and cycloplegia.
| Study group | Role | What they receive |
|---|---|---|
| Clinical prototype (CP1) device | Experimental | 15 subjects will be randomly assigned to use the eSpectacle Clinical Prototype (CP1) device 2 hours per day, at least 6 days per week. Standard single vision correction will be used during other waking hours. The eSpectacle clinical prototype (CP1) device consists of a clear 15° central aperture and projects +9.00D defocused micro-LED lights onto the peripheral retina. Receives: Device: eSpectacle Clinical prototype (CP1) device |
| CP1 and 0.01% atropine | Experimental | 15 subjects will be randomly assigned to use the eSpectacle Clinical Prototype (CP1) device 2 hours per day, at least 6 days per week, in addition to nightly instillation of one drop of 0.01% atropine. Standard single vision correction will be used during other waking hours. The eSpectacle clinical prototype (CP1) device consists of a clear 15° central aperture and projects +9.00D defocused micro-LED lights onto the peripheral retina. Atropine is an anticholinergic medication which can be used for dilation and cycloplegia and has been evaluated for slowing the progression of myopia. Receives: Device: eSpectacle Clinical prototype (CP1) device; Drug: 0.01% atropine |
| 0.01% atropine | Experimental | 15 subjects will be randomly assigned to nightly instillation of one drop of 0.01% atropine without use of the eSpectacle clinical prototype (CP1) device. Standard single vision correction will be used during waking hours. Atropine is an anticholinergic medication which can be used for dilation and cycloplegia and has been evaluated for slowing the progression of myopia. Receives: Drug: 0.01% atropine |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSER
Difference in the changes of cycloplegic spherical refractive error between each of the three treatment groups.
Measured: 12 months
AL
Difference in the changes of axial length between each of the three treatment groups.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Oct 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kubota Vision Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- China Medical University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034379
- Sponsor's protocol ID
- CP1:73200-TW
- Status last verified
- Dec 2024
- First submitted
- 26 Aug 2023
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kubota Corrective Spectacles and Low Dose Atropine for Slowing Myopic Progression in Taiwanese Children
- ClinicalTrials.gov ID
- NCT06034379
- Acronym / sponsor ID
- CP1:73200-TW
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Kubota Vision Inc.Industry (pharma, biotech, devices)
- Collaborators
- China Medical University Hospital
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 Sep 2023 (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 bilateral, dispensing, masked, randomized clinical trial. Myopic children will be randomly assigned to one of the following: (1) Investigational clinical prototype (CP1) device without atropine, (2) Investigational CP1 device with daily instillation of 0.01% atropine, or (3) daily instillation of 0.01% atropine without use of the investigational CP1 device. Primary endpoint: Difference in the 12-month change of cycloplegic spherical refractive error and axial length between each of the three treatment groups.
Detailed description
The eSpectacle clinical prototype (CP1) device consists of a clear 15° central aperture and projects +9.00D defocused micro-LED lights onto the peripheral retina. In this pilot investigation, we aim to observe the ocular biometric and refractive changes following part-time wear of the clinical prototype device over a course of 12 months.
This trial is bilateral, dispensing, masked, and randomized (stratified by age). Myopic children will be randomly assigned to one of the following: (1) CP1 device without atropine, (2) CP1 device with daily instillation of 0.01% atropine, or (3) daily instillation of 0.01% atropine without use of the CP1 device.
A total of 45 subjects (15 per subgroup) are targeted to complete the study, which will consist of 8 visits: Screening, baseline/dispense, 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months. Subjects will be enrolled from the patient population at the investigator site.
The primary objective is to evaluate the effectiveness of the eSpectacle clinical prototype device with and without the use of 0.01 percent atropine for slowing the progression of myopia in Taiwanese children, by assessing changes in central axial length and cycloplegic autorefraction following at least 12 hours per week of wear over 12 months. To minimize bias, the primary outcome variables of cycloplegic autorefraction and axial length will be measured by a Masked Investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clinical prototype (CP1) device | Experimental | Device: eSpectacle Clinical prototype (CP1) device15 subjects will be randomly assigned to use the eSpectacle Clinical Prototype (CP1) device 2 hours per day, at least 6 days per week. Standard single vision correction will be used during other waking hours. The eSpectacle clinical prototype (CP1) device consists of a clear 15° central aperture and projects +9.00D defocused micro-LED lights onto the peripheral retina. |
| CP1 and 0.01% atropine | Experimental | Device: eSpectacle Clinical prototype (CP1) device, Drug: 0.01% atropine15 subjects will be randomly assigned to use the eSpectacle Clinical Prototype (CP1) device 2 hours per day, at least 6 days per week, in addition to nightly instillation of one drop of 0.01% atropine. Standard single vision correction will be used during other waking hours. The eSpectacle clinical prototype (CP1) device consists of a clear 15° central aperture and projects +9.00D defocused micro-LED lights onto the peripheral retina. Atropine is an anticholinergic medication which can be used for dilation and cycloplegia and has been evaluated for slowing the progression of myopia. |
| 0.01% atropine | Experimental | Drug: 0.01% atropine15 subjects will be randomly assigned to nightly instillation of one drop of 0.01% atropine without use of the eSpectacle clinical prototype (CP1) device. Standard single vision correction will be used during waking hours. Atropine is an anticholinergic medication which can be used for dilation and cycloplegia and has been evaluated for slowing the progression of myopia. |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- The subject must be between 6 and 13 years of age (inclusive).
- The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol.
- The guardian of a minor under 18 years old must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form. The subject under 18 years old must be willing to assent to the STATEMENT OF INFORMED CONSENT.
- Spherical component of refraction in the range of -0.50 to -10.00 DS in each eye.
- Refractive cylinder less than or equal to 2.00 DC in each eye (minus cylinder format).
Key exclusion criteria (10 listed)
- Currently pregnant or lactating
- History of severe dry eye, strabismus, or amblyopia
- Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g., diabetes, rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with the participation in the study at the investigator's discretion.
- Use of systemic or ocular medications (e.g., chronic steroid use) that are known to interfere with vision and ocular accommodation at the investigator's discretion.
- Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, strabismus surgery etc.) or orthokeratology
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 |
|---|---|---|
| eSpectacle Clinical prototype (CP1) deviceThe CP1 device consists of a clear 15° central aperture and projects +9.00D defocused micro-LED lights of approximately 4800 nits illumination to the peripheral retina. | Device | CP1 and 0.01% atropine, Clinical prototype (CP1) device |
| 0.01% atropineAtropine is a and anticholinergic medication which can be used for dilation and cycloplegia. | Drug | 0.01% atropine, CP1 and 0.01% atropine |
Primary outcome
CSER
Time frame: 12 months
Difference in the changes of cycloplegic spherical refractive error between each of the three treatment groups.
AL
Time frame: 12 months
Difference in the changes of axial length between each of the three treatment groups.
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 Dec 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eSpectacle Clinical prototype (CP1) device and 0.01% atropine in people with Myopia, run by Kubota Vision Inc. at 1 site in Taiwan.
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 6 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 12 Dec 2024. 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 Taiwan. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSER (time frame: 12 months). The study lists 2 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 12 Dec 2024.