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Compares treatment options for Myopia
Official title Electronic Spectacles Versus Low Dose Atropine in Young Myopes
ClinicalTrials.gov ID: NCT06034379
What this study is testing
What is 0.01% atropine?
0.01% atropine is an investigational medicine, given as an once-daily, being studied as a potential treatment for myopia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 13. Healthy volunteers may be eligible.
You may be able to join 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...
- 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).
You likely can't join 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...
- Use of systemic or ocular medications (e.g., chronic steroid use) that are known to interfere with vision and ocular accommodation at the...
- Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, strabismus surgery etc.) or...
- Any active ocular infection.
See the full eligibility criteria
- 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...
- 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Hsinchu, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 13 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hsinchu, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.