Electronic Spectacles Versus Low Dose Atropine in Young Myopes
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% atropi
| Condition(s) | Myopia |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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% 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. |
| Who can participate | Inclusion Criteria: 1. The subject must be between 6 and 13 years of age (inclusive). 2. The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol. 3. 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. 4. Spherical component of refraction in the range of -0.50 to -10.00 DS in each eye. 5. Refractive cylinder less than or equal to 2.00 DC in each eye (minus cylinder format). 6. Best corrected distance VA of at least 20/25 in each eye. Exclusion Criteria: 1. Currently pregnant or lactating 2. History of severe dry eye, strabismus, or amblyopia 3. Any systemic disease (e.g |
| Ages | 6 Years to 13 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Kubota Vision Inc. |
| Locations | Hsinchu, Taiwan |
| Start date | 2023-10-01 |
| NCT ID | NCT06034379 |
| Official listing | https://clinicaltrials.gov/study/NCT06034379 |