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Electronic Spectacles Versus Low Dose Atropine in Young Myopes

Myopia Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06034379
Study type Interventional
Source Kubota Vision Inc.
Contact
Status Not yet recruiting
Phase N/A
Start date October 2023
Completion date March 2025
View Details
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