Comparing electronic spectacles and low dose atropine for myopia in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of an electronic spectacle prototype and low-dose atropine in slowing myopia progression in children aged 6 to 13. Participants will be randomly assigned to one of three groups: wearing the electronic device alone, wearing it with daily atropine drops, or using atropine drops without the device. The study will measure changes in refractive error and axial length over 12 months, with assessments conducted at multiple time points. The trial aims to provide insights into innovative treatments for myopia in a pediatric population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. The subject must be between 6 and 13 years of age (inclusive).
2. The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol.
3. 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.
4. Spherical component of refraction in the range of -0.50 to -10.00 DS in each eye.
5. Refractive cylinder less than or equal to 2.00 DC in each eye (minus cylinder format).
6. Best corrected distance VA of at least 20/25 in each eye.

Exclusion Criteria:

1. Currently pregnant or lactating
2. History of severe dry eye, strabismus, or amblyopia
3. 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.
4. 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.
5. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, strabismus surgery etc.) or orthokeratology
6. Any active ocular infection.
7. Any accommodative or binocular anomalies including amblyopia.
8. Any physical or mental developmental delay.
9. 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)
10. Anisometropia greater than 1.50D

Where it's running

• CMU Hsinchu Hospital
  Hsinchu, Taiwan Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating a device for screening vision problems in young children

  This study is testing a new device to see if it can effectively find vision problems in children aged 3 to 8, whether they wear glasses or not.

  Recruiting Essilor International · Nancy, France and 1 other locations · NCT06882408

• Optimizing light exposure to prevent and control myopia in children

  This study tests if changing classroom lighting to mimic sunlight or using a smartphone app to guide light exposure can help prevent and control myopia in primary school children.

  Recruiting at 5 sites National University of Singapore · Singapore and 4 other locations · NCT06631339

• Hyperopic reserve screening for kindergartners in Beijing

  A population-wide screening tests whether senior kindergarten children in Beijing have enough hyperopic reserve to help prevent future myopia.

  Recruiting Beijing Tongren Hospital · Beijing · NCT07851532

• Do dual-focus multifocal contact lenses improve hand-eye coordination and sports vision compared with your usual lenses

  This study tests whether wearing dual-focus multifocal contact lenses improves hand-eye coordination and sports vision in adults who play baseball or softball and normally wear contact lenses.

  Recruiting Ohio State University · Columbus, Ohio · NCT07840209

• Two monthly silicone hydrogel multifocal toric contact lenses in wearers with astigmatism and myopia

  This study tests whether two popular soft multifocal toric contact lenses perform differently in adults who need vision correction for astigmatism and myopia.

  Recruiting CooperVision International Limited (CVIL) · New York, New York and 2 other locations · NCT07829419

• Seeing clearly in low light after Ray-Tracing guided LASIK

  A trial tests how well WaveLight Plus LASIK works for people with myopia and astigmatism and whether patients are satisfied after the procedure.

  Recruiting Phase 4 Vance Thompson Vision · Sioux Falls, South Dakota · NCT07790185

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.