NCT05917041

Brief Summary

The Purpose of this study is to explore the safety and effectiveness of SAT-001, a medical device for the treatment of myopia in pediatric patient with myopia

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2024

Completed
Last Updated

May 3, 2024

Status Verified

June 1, 2023

Enrollment Period

2.1 years

First QC Date

June 12, 2023

Last Update Submit

May 2, 2024

Conditions

Children Myopia

Outcome Measures

Primary Outcomes (2)

  • Change in cycloplegic Refraction Error

    Baseline, 24 weeks, 48 weeks

  • Change in axial length

    Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks

Study Arms (2)

SAT-001

EXPERIMENTAL
Device: SAT-001(Software as Medical Device)

Control Group

NO INTERVENTION

Wearing glasses or not

Interventions

SAT-001(Software as Medical Device)DEVICE

Using SAT-001 application for 48 weeks and wearing glasses or not

SAT-001

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Pediatric patient age 5 to 12 years old at the Screening Visit
  • Diagnosed with myopia as following refractive error via cycloplegic refraction(CR)
  • Spherical equivalent (SE) -0.75 D or more and less than -6.00 D in each eye
  • Astigmatism of 1.50 D or less in each eye
  • Anisometropia of less than 1.00 D
  • The age of birth over 38 weeks
  • Over 2500g of birth weight
  • Best corrected distance visual acuity of 0.2 logMAR or better in each eye at the Screening Visit
  • Intraocular pressure 21 mmHg or less in each eye at the Screening Visit

You may not qualify if:

  • Administration of anti-muscarine drugs within 1 month before screening visit
  • Current or previous use of multi-focal lenses
  • Planning to use or having used Orthokeratology lenses (Ortho-K lenses), Rigid Gas Permeable (RGP) lenses, and other contact lenses to reduce the progression of myopia
  • History of atropine use for treatment of myopia within 1 month before screening visit
  • Abnormal conditions in cornea, lens, central retina, iris and ciliary bodies or malignant tumors around orbit
  • History of manifest strabismus, intermittent strabismus, amblyopia, nystagmus etc. (except for phoria maintaining binocular vision)
  • History of ophthalmic surgery, such as eyelid surgery, strabismus surgery, intraocular surgery, or refractive correction surgery (except for epiblepharon surgery)
  • Obsessive-compulsive disorder or attention deficit hyperactivity disorder(ADHD)
  • Down's syndrome or cerebral palsy
  • Participation in another clinical trial within 6 months before screening visit
  • History of growth hormone treatment within 1 month before screening visit
  • Medically clear to have abnormal range of intellectual development
  • Significant systemic diseases such as congenital heart disease, respiratory system disease (except for asthma), endocrine disease or nervous system disease
  • Currently taking or having taken antihistamines (tablets, nasal spray, eye drops, etc.) or psychiatric drugs (antidepressants, anti-anxiety medications, etc.) within 30 days before screening visit
  • History of injections with histamine release and cholinergic effect within 30 days before screening visit
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

HanGil Eye Hospital

Incheon, South Korea

Location

Kangbuk Samsung Medical Center

Seoul, South Korea

Location

Konkuk University Medical Center

Seoul, South Korea

Location

Nowon Eulji Medical Center, Eulji University

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2023

First Posted

June 23, 2023

Study Start

March 5, 2021

Primary Completion

April 19, 2023

Study Completion

April 3, 2024

Last Updated

May 3, 2024

Record last verified: 2023-06

Locations

KR(6)