Electronic Spectacles Versus Low Dose Atropine in Young Myopes
Recruiting
N/A
Interventional Study
Myopia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 6 – 13
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 45 (estimated)
- Sponsor
- Kubota Vision Inc. · Industry
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About This Trial
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 i…
Trial Locations
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Eligibility Criteria
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 …
Contacts
No contact information available.