An observational study in Myopia, sponsored by S-Alpha Therapeutics, Inc.. Recruiting at 5 sites in Korea, Republic of. Open to participants aged 5 Years to 8 Years. Per ClinicalTrials.gov, last updated 2025-01-09.
Sponsored by S-Alpha Therapeutics, Inc. · Observational
The objective of this clinical trial is to collect data on the rebound effect and long-term safety of SAT-001, a Software as a Medical Device (SaMD) under development for the inhibition and treatment of myopia progression in pediatric patients.
Myopia treatments to date have included both pharmacological and non-pharmacological approaches, with some studies showing effects in reducing myopia progression. However, previous research has also identified a rebound effect, where myopia progresses rapidly after treatment cessation during follow-up. Since myopia progression in children often continues for more than two years, this rebound effect could be a critical factor in determining treatment strategies for pediatric myopia.
This multi-center, open-label, controlled observational study is an extension of a previous confirmatory trial (SAT-001-KP-002) that evaluated SAT-001, a Software as a Medical Device (SaMD) designed to slow myopia progression in pediatric patients. The current study aims to assess the rebound effect and long-term safety of SAT-001 in participants who completed the previous trial, and to collect additional data on rebound myopia and long-term safety outcomes following the completion of the initial trial. A total of 40 participants, aged 5 to less than 9 years, from both the treatment and control groups of the prior study will be followed for 6 months after completing the original trial. Participants from the previous trial who had less than 70% compliance will be excluded from this study. Both groups will continue wearing spectacles, the conventional treatment for myopia, during the extension phase. The primary endpoint is the change in cycloplegic spherical equivalent refractive error (SER) from baseline to 24 weeks, while secondary endpoints include changes in SER at 12 weeks and changes in axial length at 12 and 24 weeks compared to baseline.
984 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's planned enrollment of 40 is below the median of 150 across 173 observational studies indexed under Myopia.
Browse Myopia studies →S-Alpha Therapeutics, Inc. is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
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The study population consists of children aged 5 to 8 years at the time of their participation in the previous confirmatory trial (SAT-001-KP-002), who are continuing in the extension study. Participants will remain in their original groups (study or control group) with no new randomization.
Exclusion Criteria:
This group consists of pediatric participants who were previously assigned to receive SAT-001 along with single vision spectacles as part of the SAT-001 confirmatory trial (SAT-001-KP-002). In the extension phase, these participants will continue wearing single vision spectacles, but will no longer receive SAT-001 treatment. The aim is to monitor rebound myopia and long-term safety after the completion of the initial trial, focusing on any changes in refractive error and axial length, as well as any adverse effects associated with the cessation of SAT-001 use.
Other: Single vision spectacles
This group consists of pediatric participants who were assigned to the control group during the SAT-001 confirmatory trial and received only single vision spectacles. In the extension phase, they will continue wearing spectacles to assess rebound myopia and long-term safety, without the addition of SAT-001 treatment.
Other: Single vision spectacles
Other interventions for myopia treatment, except for glasses, will not be provided.
change in spherical equivalent refractive error
change in spherical equivalent refractive error at 24 weeks from baseline
Time frame: baseline, 24 weeks
change in spherical equivalent refractive error
change in spherical equivalent refractive error at 12- and 24-week from baseline
Time frame: Baseline, 12 weeks, 24 weeks
change in axial length
change in axial length at 12-week and 24-week from baseline
Time frame: Baseline, 12 weeks, 24 weeks
Plan to share: No
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S-Alpha Therapeutics, Inc.