Electronic Spectacles Versus Low Dose Atropine in Young Myopes

NCT06034379 | Recruiting DMC

• 1 other identifier: CP1:73200-TW
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• CSER

  Difference in the changes of cycloplegic spherical refractive error between each of the three treatment groups.

  12 months

• AL

  Difference in the changes of axial length between each of the three treatment groups.

  12 months

Study Arms (3)

Clinical prototype (CP1) device

EXPERIMENTAL

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

CP1 and 0.01% atropine

EXPERIMENTAL

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

0.01% atropine

EXPERIMENTAL

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

Interventions

eSpectacle Clinical prototype (CP1) device 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.

CP1 and 0.01% atropine; Clinical prototype (CP1) device

0.01% atropine DRUG

Atropine is a and anticholinergic medication which can be used for dilation and cycloplegia.

0.01% atropine; CP1 and 0.01% atropine

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The subject must be between 6 and 13 years of age (inclusive).
• The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol.
• The guardian of a minor under 18 years old must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form. The subject under 18 years old must be willing to assent to the STATEMENT OF INFORMED CONSENT.
• Spherical component of refraction in the range of -0.50 to -10.00 DS in each eye.
• Refractive cylinder less than or equal to 2.00 DC in each eye (minus cylinder format).
• Best corrected distance VA of at least 20/25 in each eye.

You may not qualify if:

• Currently pregnant or lactating
• History of severe dry eye, strabismus, or amblyopia
• Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g., diabetes, rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with the participation in the study at the investigator's discretion.
• Use of systemic or ocular medications (e.g., chronic steroid use) that are known to interfere with vision and ocular accommodation at the investigator's discretion.
• Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, strabismus surgery etc.) or orthokeratology
• Any active ocular infection.
• Any accommodative or binocular anomalies including amblyopia.
• Any physical or mental developmental delay.
• Any relevant ocular or systemic condition deemed unacceptable by the investigator that may negatively impact the subject's performance or ability to successfully complete the study (at the investigator's discretion)
• Anisometropia greater than 1.50D

Sponsors & Collaborators

• Kubota Vision Inc.: lead
• China Medical University Hospital: collaborator

Study Sites (1)

CMU Hsinchu Hospital

Hsinchu, Taiwan

RECRUITING

MeSH Terms

Conditions

Myopia

Interventions

Atropine

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2023
• First Posted: September 13, 2023
• Study Start: October 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

TW (1)