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Electronic Spectacles Versus Low Dose Atropine in Young Myopes

NCT06034379 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-12-12

No results posted yet for this study

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.

Conditions

  • Myopia

Interventions

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.

Sponsors & Collaborators

  • China Medical University Hospital

    collaborator OTHER

  • Kubota Vision Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06034379 on ClinicalTrials.gov