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Recruiting Phase 2 NCT07390500

NCT07390500 Assessment of the Efficacy and Safety of a DYnaMic Peripheral DegradatiON Myopia Disorder Control in Myopic Children ״DYMOND Study״

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Clinical Trial Summary
NCT ID NCT07390500
Status Recruiting
Phase Phase 2
Sponsor NovaSight
Condition Myopia
Study Type INTERVENTIONAL
Enrollment 150 participants
Start Date 2025-12-24
Primary Completion 2027-06

Eligibility & Interventions

Sex All sexes
Min Age 6 Years
Max Age 12 Years
Study Type INTERVENTIONAL
Interventions
TrackSight

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 150 participants in total. It began in 2025-12-24 with a primary completion date of 2027-06.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

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.

Contact & Investigator

Central Contact

Oren Yehezkel, PhD

✉ oren@nova-sight.com

📞 972544552568

Frequently Asked Questions

Who can join the NCT07390500 clinical trial?

This trial is open to participants of all sexes, aged 6 Years or older, up to 12 Years, studying Myopia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT07390500 trial and what does that mean for participants?

Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.

Is NCT07390500 currently recruiting?

Yes, NCT07390500 is actively recruiting participants. Contact the research team at oren@nova-sight.com for enrollment information.

Where is the NCT07390500 trial being conducted?

This trial is being conducted at Rehovot, Israel.

Who is sponsoring the NCT07390500 clinical trial?

NCT07390500 is sponsored by NovaSight. The trial plans to enroll 150 participants.

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