RecruitingPhase 2NCT07390500

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

Randomized Controlled Double Masked, Trial to Assess the Efficacy and Safety of a DYnaMic Peripheral DegradatiON Myopia Disorder Control in Myopic Children Compared to No Treatment (DYMOND Study)


Sponsor

NovaSight

Enrollment

150 participants

Start Date

Dec 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 6 YearsMax Age: 12 Years

Inclusion Criteria7

  • Aged 6-12 years
  • Diagnosed with myopia: cycloplegic spherical or spherical equivalent (SER) between -0.75D and -5.00D, astigmatism ≤ -1.50D, anisometropia \< 1.50D
  • Visual acuity 20/32 or better (age-appropriate testing) in both eyes
  • Interocular VA difference ≤1.00 logMAR line
  • Subject in general good health and able, as per investigator decision, to comply with study visits and protocol procedures
  • The subject is using digital devices for at least 1 hour/day regularly according to parental report
  • Signed informed consent by legal parent/guardian and assent approval -. Currently wearing single vision refractive correction

Exclusion Criteria6

  • Past or concurrent use of any other myopia treatment (e.g., atropine, orthokeratology, myopia control glasses/lenses)
  • Eye diseases or abnormality, developmental conditions, or past ocular surgeries or any other condition which could potentially affect refraction or AL progression according to the investigator's judgement
  • Current or prior history of manifest strabismus, amblyopia, or nystagmus
  • Subject cannot pass eye tracking calibration in at least 50% of cases, or cannot be tracked in at least 50% of the time during a screening eligibility test
  • Current or previous use of bifocal lenses, progressive-addition lenses, or multi-focal contact lenses
  • Premature gestational age ≤32 weeks or birth weight \<1500g.

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Interventions

DEVICETrackSight

applying a predefined combination of peripheral chromatic blur and contrast reduction during normal screen use


Locations(1)

Kaplan MC

Rehovot, Israel

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NCT07390500


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