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

NCT07390500 | Recruiting Phase 2

• 1 other identifier: NS-01317
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myopia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• change in axial length

  change in axial length (AL) of the eye used to assess whether TrackSight™ slows eye growth compared with the control condition.

  12 months

Study Arms (3)

TrackSight™ with active peripheral image degradation (blur)

EXPERIMENTAL

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.

Device: TrackSight

rackSight™ with active peripheral image degradation (contrast)

EXPERIMENTAL

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.

Device: TrackSight

TrackSight™ with the peripheral image degradation function disabled (control).

SHAM COMPARATOR

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.

Device: TrackSight

Interventions

TrackSight DEVICE

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

TrackSight™ with active peripheral image degradation (blur); TrackSight™ with the peripheral image degradation function disabled (control).; rackSight™ with active peripheral image degradation (contrast)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NovaSight: lead

Study Sites (1)

Kaplan MC

Rehovot, Israel

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Oren Yehezkel, PhD

CONTACT

972544552568; oren@nova-sight.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, parents, investigators, and study staff do not know whether the active visual feature is enabled.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 5, 2026
• Study Start: December 24, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)