DYMOND: TrackSight peripheral-vision myopia control for children

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)

This study will see if TrackSight, an eye-tracking app, can slow nearsightedness progression in children aged 6–12 during their regular screen use.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 6 Years to 12 Years
• Sex: All
• Sponsor: NovaSight (Industry-sponsored)
• Locations: 1 site (Rehovot)
• Trial ID: NCT07390500 on ClinicalTrials.gov

What this trial studies

Up to 150 children with mild to moderate myopia at sites in Israel and Hong Kong will be randomized to use TrackSight with one of two active peripheral-adjustment settings or a non-adjusting control while continuing their usual single-vision glasses for 12 months. TrackSight uses real-time eye tracking to keep central vision clear while applying controlled visual changes to peripheral screen areas intended to influence eye growth. Participants will have baseline, 6-month, and 12-month eye exams and safety assessments including refraction and axial length measurements. The trial compares progression rates and safety outcomes between groups to determine whether the digital approach reduces myopia progression during everyday screen use.

Who should consider this trial

Good fit: Children aged 6–12 with cycloplegic spherical equivalent between −0.75 D and −5.00 D, astigmatism ≤1.50 D, currently wearing single-vision glasses, and who use digital devices at least one hour per day.

Not a fit: Children already using other myopia control treatments, with ocular disease, prior ocular surgery, or refractive errors outside the enrollment ranges are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the app could provide a noninvasive way to slow childhood myopia progression without changing eyeglass prescriptions or adding drugs or contact lenses.

How similar studies have performed: Specialized spectacle and contact lens approaches that create peripheral defocus have shown reductions in myopia progression, but software-delivered peripheral defocus during screen use is a newer approach with limited prior clinical data.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Rehovot

• Kaplan MC — Rehovot, Israel (Recruiting)

Study contacts

• Study coordinator: Oren Yehezkel, PhD

Conditions Myopia; Myopia, myopia control, TrackSight, real-time eye-tracking technology