An interventional study of eSpectacle Clinical prototype (CP1) device and 0.01% atropine in Myopia, sponsored by Kubota Vision Inc.. Recruiting at 1 site in Taiwan. Open to participants aged 6 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-12.
Sponsored by Kubota Vision Inc. · Not applicable, Interventional, and Treatment
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.
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.
984 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's planned enrollment of 45 is below the median of 80 across 783 interventional studies indexed under Myopia.
Browse Myopia studies →Kubota Vision Inc. is the lead sponsor of 21 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
15 subjects will be randomly assigned to use the eSpectacle Clinical Prototype (CP1) device 2 hours per day, at least 6 days per week. Standard single vision correction will be used during other waking hours. 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.
Device: eSpectacle Clinical prototype (CP1) device
15 subjects will be randomly assigned to use the eSpectacle Clinical Prototype (CP1) device 2 hours per day, at least 6 days per week, in addition to nightly instillation of one drop of 0.01% atropine. Standard single vision correction will be used during other waking hours. 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. Atropine is an anticholinergic medication which can be used for dilation and cycloplegia and has been evaluated for slowing the progression of myopia.
Device: eSpectacle Clinical prototype (CP1) device · Drug: 0.01% atropine
15 subjects will be randomly assigned to nightly instillation of one drop of 0.01% atropine without use of the eSpectacle clinical prototype (CP1) device. Standard single vision correction will be used during waking hours. Atropine is an anticholinergic medication which can be used for dilation and cycloplegia and has been evaluated for slowing the progression of myopia.
Drug: 0.01% atropine
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.
Atropine is a and anticholinergic medication which can be used for dilation and cycloplegia.
CSER
Difference in the changes of cycloplegic spherical refractive error between each of the three treatment groups.
Time frame: 12 months
AL
Difference in the changes of axial length between each of the three treatment groups.
Time frame: 12 months
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Kubota Vision Inc.