Using SAT-001 to treat 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 investigation aims to evaluate the efficacy and safety of SAT-001, a Software as Medical Device (SaMD), in slowing the progression of myopia in pediatric patients. The study is designed as a confirmatory clinical trial following an exploratory trial, focusing on children aged 5 to less than 9 years with specific refractive criteria. Participants will use SAT-001 alongside single vision spectacles to assess its impact on myopia progression. The trial will involve rigorous monitoring and evaluation of visual acuity and refractive error.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Children aged 5 to less than 9
2. Meet the following refractive criteria by cycloplegic refraction

   1. Spherical equivalent refractive error (SER): -0.75 to less than -6.00 D in each eye
   2. Astigmatism of 1.50 D or less in each eye
   3. Anisometropia of 2.00 D or less
3. Best corrected visual acuity of 0.2 logMAR or better in each eye at the Screening Visit
4. Able to successfully accomplish SAT-001, the investigational device (able to follow the written and verbal instruction)
5. Subjects and their legal guardians who agree to participate in the clinical trial and are willing to provide the signed informed consent after receiving and comprehending the explanation of the description of this clinical trial (subject under 6 can make a mark for agreement after full information and understanding)

Exclusion Criteria:

1. History of atropine use within 3 days prior to Baseline (Visit 2) (prior treatment of myopia control with low dose atropine within 1 month prior to Baseline)
2. Current or prior use of multifocal lenses (e.g. progressive addition lenses), orthokeratology (Ortho-K, e.g. Dream lens), or Rigid gas permeable (RGP) within 1month prior to Baseline(Visit 2)
3. Ocular abnormalities in cornea, lens, central retina, iris, ciliary body, etc., or presence of malignant tumors in the orbital area
4. History of eye diseases such as manifest strabismus, intermittent strabismus, amblyopia, and nystagmus (excluding strabismus that maintains binocular vision)
5. History of ocular surgery such as eyelid surgery, strabismus surgery, intraocular surgery, or refractive correction surgery (excluding simple double eyelid surgery)
6. Down's syndrome or cerebral palsy
7. Within 6 months prior to the Screening visit (Visit 1), has experience of other clinical trial medications or investigational device
8. Clinically significant systemic diseases such as congenital heart disease, respiratory disease, endocrine disease, and neurological disease that the investigator may consider inappropriate for participation in the clinical trials
9. Systemic diseases that could impact both vision and visual field
10. History of growth hormone treatment within 1 month prior to Baseline (Visit 2)
11. Other reasons for participation in the trial at the discretion of the investigator

Where it's running

• Gachon University Gil Hospital
  Incheon, South Korea Recruiting

Study contacts

• Study coordinator: YS Park
• Email: sat-001p@salphadtx.com
• Phone: +82-2-3487-3922

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.