Assessment of the Efficacy and Safety of a DYnaMic Peripheral DegradatiON Myopia Disorder Control in Myopic Children ״DYMOND Study״

Sponsor
NovaSight
Study ID
NCT07390500
Phase
PHASE2
Status
Recruiting
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Conditions

  • Myopia

Eligibility Criteria

Sex
ALL
Age
6 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • TrackSight — DEVICE
    applying a predefined combination of peripheral chromatic blur and contrast reduction during normal screen use

Study Details

The DYMOND study evaluates the safety and effectiveness of TrackSight™, a digital medical application designed to slow myopia (nearsightedness) progression in children during everyday screen use. TrackSight uses eye-tracking technology to keep central vision clear while subtly adjusting the image in the peripheral viewing area, based on established scientific principles known to influence eye growth. Up to 150 children aged 6 to 12 with myopia will participate at sites in Israel and Hong Kong. All participants will continue wearing their regular single-vision glasses and will be randomly assigned to use TrackSight with or without active visual adjustment for 12 months. Eye examinations and safety assessments will be conducted at the start of the study and after 6 and 12 months. The study aims to determine whether this non-invasive digital approach can safely slow myopia progression in children.

Key Dates

First listed
Feb 5, 2026
Start date
Dec 24, 2025
Status verified
Jan 2026
Primary completion
Jun 30, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TrackSight™ with active peripheral image degradation (blur)
    Participants use TrackSight™ with active peripheral image degradation enabled using combination #1 during their normal screen activities. Central vision remains clear while the peripheral image is digitally modified. Standard single-vision glasses are worn at all times.
  • Experimental: rackSight™ with active peripheral image degradation (contrast)
    Participants use TrackSight™ with active peripheral image degradation enabled using combination #2, which applies a different level or pattern of visual modification during screen use. Central vision is unaffected, and standard single-vision glasses are worn throughout the study.
  • Sham Comparator: TrackSight™ with the peripheral image degradation function disabled (control).
    Participants use the same TrackSight™ software and device, but the peripheral image degradation feature is disabled. Screen use and standard single-vision glasses remain unchanged, serving as the control condition.

Primary Outcome Measure

change in axial length [ Time Frame: 12 months ]

Central Contacts

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