Electronic Spectacles Versus Low Dose Atropine in Young Myopes
Study Details
Study Description
Brief Summary
This is a bilateral, dispensing, masked, randomized clinical trial. Myopic children will be randomly assigned to one of the following: (1) Investigational 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 changes of cycloplegic spherical refractive error and axial length between each of the three treatment groups.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CP1 2 hours per day of CP1 study device use |
Device: CP1
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.
|
| Experimental: CP1 and 0.01% atropine 2 hours per day of CP1 study device use and nightly instillation of one drop of 0.01% atropine |
Device: CP1
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.
Drug: 0.01% atropine
Atropine is a and anticholinergic medication which can be used for dilation and cycloplegia.
|
| Experimental: 0.01% atropine Nightly instillation of one drop of 0.01% atropine |
Drug: 0.01% atropine
Atropine is a and anticholinergic medication which can be used for dilation and cycloplegia.
|
Outcome Measures
Primary Outcome Measures
- CSER [12 months]
Difference in the changes of cycloplegic spherical refractive error between each of the three treatment groups.
- AL [12 months]
Difference in the changes of axial length between each of the three treatment groups.
Eligibility Criteria
Criteria
Inclusion Criteria:
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The subject must be between 6 and 13 years of age (inclusive).
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The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol.
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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.
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Spherical component of refraction in the range of -0.50 to -10.00 DS in each eye.
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Refractive cylinder less than or equal to 2.00 DC in each eye (minus cylinder format).
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Best corrected distance VA of at least 20/25 in each eye.
Exclusion Criteria:
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Currently pregnant or lactating
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History of severe dry eye, strabismus, or amblyopia
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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.
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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.
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Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, strabismus surgery etc.) or orthokeratology
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Any active ocular infection.
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Any accommodative or binocular anomalies including amblyopia.
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Any physical or mental developmental delay.
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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)
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Anisometropia greater than 1.50D
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Kubota Vision Inc.
- China Medical University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CP1:73200-TW