MyopiaPhase 2DYMONDNCT07390500
Assessment of the Efficacy and Safety of a DYnaMic Peripheral DegradatiON Myopia Disorder Control in Myopic Children ״DYMOND Study״
A Phase 2 study testing TrackSight in people with Myopia, run by NovaSight at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Myopia
- What is being tested?
- TrackSight
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- 24 Dec 2025to Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Kaplan MC
Rehovot
Reut Parnas, MD, 972-8-9441353, reutyos@clalit.org.il
Tamara Wygnanski Yafe, MD, 972-50-2436072, twjaffe@hotmail.com
About this study
Official title: 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)
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.
Read the detailed description
The DYMOND study is a clinical research study designed to evaluate the safety and effectiveness of a digital application called TrackSight™ for slowing the progression of myopia (nearsightedness) in children. Myopia often worsens during childhood, particularly during activities that involve prolonged screen use, such as studying, gaming, or watching videos. This study explores whether a software-based approach can help reduce the rate of myopia progression during everyday screen use.
TrackSight™ is a software medical device that uses real-time eye-tracking technology to subtly adjust the visual information presented on a digital screen. While central vision remains clear at all times, the software applies controlled visual changes to the peripheral areas of the screen. These changes are designed to influence how the eye grows, based on established scientific principles that have been shown to slow myopia progression in studies using special spectacle and contact lenses. TrackSight delivers these same principles digitally, without altering standard vision correction.
Up to 150 children between the ages of 6 and 12 with mild to moderate myopia will participate in the study at clinical sites in Israel and Hong Kong. All children will continue wearing their regular single-vision glasses throughout the study. Participants will be randomly assigned to one of three study groups. Two groups will use TrackSight with different active visual adjustment settings, while one group will use the same application with these features turned off. Neither the families nor the study staff will know which version of the software a child is using during the study.
Children will use the TrackSight application during their normal screen activities over a period of 12 months. Eye examinations will be performed at the start of the study and again at 6 and 12 months to measure changes in eye growth and vision. Questionnaires will be used to assess screen use, vision-related quality of life, and overall experience with the software. Safety will be closely monitored throughout the study, and families will have access to technical support if needed.
The primary goal of the study is to determine whether TrackSight can safely slow the progression of myopia by reducing eye growth over one year compared with no active treatment. The results of this study may help support a new, non-invasive digital approach to managing childhood myopia in modern screen-based environments.
- Conditions
- Myopia
- Being tested
- TrackSight
- Keywords
- Myopia, myopia control, TrackSight, real-time eye-tracking technology
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrackSightDevice
applying a predefined combination of peripheral chromatic blur and contrast reduction during normal screen use
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: TrackSight |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start24 Dec 2025
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NovaSight
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390500
- Sponsor's protocol ID
- NS-01317
- Acronym
- DYMOND
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: private sponsor study
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07390500
- Acronym / sponsor ID
- DYMOND / NS-01317
- Conditions
- Myopia
- Keywords
- Myopia, myopia control, TrackSight, real-time eye-tracking technology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- NovaSightIndustry (pharma, biotech, devices)
- Study start
- 24 Dec 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The DYMOND study is a clinical research study designed to evaluate the safety and effectiveness of a digital application called TrackSight™ for slowing the progression of myopia (nearsightedness) in children. Myopia often worsens during childhood, particularly during activities that involve prolonged screen use, such as studying, gaming, or watching videos. This study explores whether a software-based approach can help reduce the rate of myopia progression during everyday screen use.
TrackSight™ is a software medical device that uses real-time eye-tracking technology to subtly adjust the visual information presented on a digital screen. While central vision remains clear at all times, the software applies controlled visual changes to the peripheral areas of the screen. These changes are designed to influence how the eye grows, based on established scientific principles that have been shown to slow myopia progression in studies using special spectacle and contact lenses. TrackSight delivers these same principles digitally, without altering standard vision correction.
Up to 150 children between the ages of 6 and 12 with mild to moderate myopia will participate in the study at clinical sites in Israel and Hong Kong. All children will continue wearing their regular single-vision glasses throughout the study. Participants will be randomly assigned to one of three study groups. Two groups will use TrackSight with different active visual adjustment settings, while one group will use the same application with these features turned off. Neither the families nor the study staff will know which version of the software a child is using during the study.
Children will use the TrackSight application during their normal screen activities over a period of 12 months. Eye examinations will be performed at the start of the study and again at 6 and 12 months to measure changes in eye growth and vision. Questionnaires will be used to assess screen use, vision-related quality of life, and overall experience with the software. Safety will be closely monitored throughout the study, and families will have access to technical support if needed.
The primary goal of the study is to determine whether TrackSight can safely slow the progression of myopia by reducing eye growth over one year compared with no active treatment. The results of this study may help support a new, non-invasive digital approach to managing childhood myopia in modern screen-based environments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TrackSight™ with active peripheral image degradation (blur) | Experimental | Device: TrackSightParticipants 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. |
| rackSight™ with active peripheral image degradation (contrast) | Experimental | Device: TrackSightParticipants 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. |
| TrackSight™ with the peripheral image degradation function disabled (control). | Sham comparator | Device: TrackSightParticipants 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrackSightapplying a predefined combination of peripheral chromatic blur and contrast reduction during normal screen use | Device | TrackSight™ with active peripheral image degradation (blur), TrackSight™ with the peripheral image degradation function disabled (control)., rackSight™ with active peripheral image degradation (contrast) |
Primary outcome
change in axial length
Time frame: 12 months
change in axial length (AL) of the eye used to assess whether TrackSight™ slows eye growth compared with the control condition.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No. private sponsor study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TrackSight in people with Myopia, run by NovaSight at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oren Yehezkel, PhD (972544552568, oren@nova-sight.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in axial length (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.