Actively Recruiting
Electronic Spectacles Versus Low Dose Atropine in Young Myopes
Led by Kubota Vision Inc. · Updated on 2024-12-12
45
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
Sponsors
K
Kubota Vision Inc.
Lead Sponsor
C
China Medical University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Electronic Spectacles Versus Low Dose Atropine in Young Myopes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The subject must be between 6 and 13 years of age (inclusive).
- The subject must appear able and willing to follow the study instructions.
- The guardian of a minor must read and sign the informed consent, and the child must assent.
- Spherical refractive error between -0.50 and -10.00 diopters in each eye.
- Refractive cylinder of 2.00 diopters or less in each eye.
- Best corrected distance visual acuity of at least 20/25 in each eye.
You will not qualify if you...
- Currently pregnant or lactating.
- History of severe dry eye, strabismus, or amblyopia.
- Any systemic disease, allergy, infection, immunosuppressive or autoimmune disease that may interfere with study participation.
- Use of systemic or ocular medications affecting vision or accommodation.
- Previous or planned ocular surgery or orthokeratology.
- Any active eye infection.
- Accommodative or binocular anomalies including amblyopia.
- Physical or mental developmental delay.
- Any ocular or systemic condition deemed unsuitable by the investigator.
- Anisometropia greater than 1.50 diopters.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CMU Hsinchu Hospital
Hsinchu, Taiwan
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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