NCT06034379

Electronic Spectacles Versus Low Dose Atropine in Young Myopes

Kubota Corrective Spectacles and Low Dose Atropine for Slowing Myopic Progression in Taiwanese Children

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Kubota Vision Inc. · Industry
• Sex: All
• Age: 6 Years – 13 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DEVICE	eSpectacle Clinical prototype (CP1) device	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.

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-09-13
• Last updated: 2024-12-12

Locations

1 site across 1 country: Taiwan