MyopiaNCT06995911
Virtual Far-sight Reading Device for Myopia Intervention Among Pre-myopic Children
A study testing Virtual Far-sight Reading Device in people with Myopia and Pre-myopia, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
This clinical trial wants to find out if the Virtual Far-sight Reading Device can help prevent or slow down myopia progression in children and teenagers with pre-myopia. We also want to know what makes this treatment work better for some participants and check for any eye or body-related side effects over time. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Myopia, Pre-myopia
- What is being tested?
- Virtual Far-sight Reading Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 31 May 2026
- Phase
- Interventional
- 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
- Age: 6-12 years (inclusive), gender unrestricted.
- Worse eye cycloplegic spherical equivalent refraction (SER): -0.5 D < SER ≤ +0.75 D; Cylinder ≤ -1.5 D in both eyes; Interocular anisometropia ≤ 1.5 D ③ Visual acuity: Best-corrected visual acuity (BCVA) ≤ 0.1 logMAR in both eyes. ④ Family history: At least one parent with myopia.
- Intraocular pressure (IOP): 10-21 mmHg in both eyes; Interocular IOP difference ≤ 5 mmHg
- ⑥ Compliance: Commitment to daily home use of the Far-Image Light Field Desk per protocol, immediate notification to investigators if unable to comply, and completion of scheduled follow-ups.
- ⑦ Informed consent: Signed assent form (minor) and written informed consent from legal guardian.
Who cannot join
- Ocular comorbidities affecting vision/refractive development: Marfan syndrome; Lens pathologies (e.g., cataracts); Glaucoma; retinal detachment; retinopathy of prematurity
- Systemic diseases: Immune/CNS disorders; Down syndrome; Severe cardiopulmonary/hepatic/renal dysfunction; Uncontrolled asthma
- Ocular abnormalities: Manifest strabismus; Binocular vision dysfunction; Pathological ocular changes or active ocular inflammation ④ Recent myopia interventions (within 3 months prior to screening): Orthokeratology; multifocal contact lenses; Functional spectacles, red-light therapy
- ⑤ Medications affecting efficacy evaluation (within 3 months): Anticholinergics (e.g., atropine, pirenzepine); Cholinergics (e.g., pilocarpine)
- ⑥ Participation in other clinical trials within 3 months.
- ⑦ Contraindications/allergies to cycloplegics or study-related medications.
- ⑧ Chronic psychiatric disorders or cognitive impairment.
- ⑨ Other conditions deemed unsuitable by investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Eye Disease Prevention and Treatment Center
Shanghai
Tianyu Cheng, Dr, +86 18817552005, s70444@126.com
About this study
Official title: A Randomized Controlled Clinical Trial on the Efficacy and Safety of the Virtual Far-sight Reading Device for Myopia Intervention in Pre-myopic Children
This clinical trial wants to find out if the Virtual Far-sight Reading Device can help prevent or slow down myopia progression in children and teenagers with pre-myopia. We also want to know what makes this treatment work better for some participants and check for any eye or body-related side effects over time.
Main questions:
Read more
Can using the Virtual Far-sight Reading Device reduce the risk of myopia? Is the device safe to use every day for up to 6 months?
What we'll do:
Researchers will compare two groups of children:
Group A: Uses the device for reading/writing (at least 1 hour daily) Group B: Does regular reading/writing without the device After 90 days, the groups will switch to see if the results stay the same.
Participants will:
- Have free eye checkups 3 times over 6 months
- Use the device during homework time (if in the desk group)
- Report any eye discomfort or problems
Read the detailed description
The Virtual Far-sight Reading Device is an innovative ocular protection device integrating advanced far-image optical technology, designed to alleviate asthenopia and prevent myopia progression by simulating a long-distance visual environment. Utilizing a birdbath optical configuration and freeform surface technology, it extends the working distance from 30 cm to over 6 meters, mimicking natural distance viewing to induce ciliary muscle relaxation. The device incorporates a cinematic-grade 2K true-color retinal display combined with a peripheral defocus optical design to generate hyperopic retinal shifts, thereby suppressing myopia development. Additional features include an embedded high-resolution AI camera, full-spectrum LED auxiliary lighting (CCT 5000K, CRI >90), and compatibility with extensive e-learning resources, making it suitable for diverse scenarios such as online classes, reading, and writing tasks.
This study employs a randomized controlled crossover trial to evaluate the efficacy and safety of the device in pre-myopic children and adolescents. Participants are divided into Groups A and B, with Phase I (Days 0-90) requiring Group A to perform daily near-work activities using the device for ≥60 minutes of cumulative daily use, while Group B follows conventional near-work practices without intervention. During Phase II (Days 91-180), the interventions are reversed between groups. Comprehensive ophthalmic evaluations are conducted at baseline, Day 90, and Day 180 to assess changes in spherical equivalent refraction (SER), axial length (AL), myopia incidence rate, binocular visual function parameters, and ocular morphological metrics, ensuring rigorous analysis of both therapeutic outcomes and safety profiles.
- Conditions
- Myopia, Pre-myopia
- Being tested
- Virtual Far-sight Reading Device
- Keywords
- Myopia, Pre-myopia
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Far-sight Reading DeviceDevice
The Virtual Far-sight Reading Device utilizes a birdbath optical configuration and freeform surface technology to extend the working distance from 30 cm to over 6 meters, thereby simulating distance viewing conditions and maintaining ciliary muscle relaxation. Study participants were required to engage in reading and writing tasks using the device for a cumulative daily duration of at least 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Nearwork with the Virtual Far-sight Reading Device | Experimental | Not described Receives: Device: Virtual Far-sight Reading Device |
| Nearwork without the Virtual Far-sight Reading Device | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Spherical Equivalent Refraction
Measured: 90 and 180 days from baseline
Secondary outcomes (2)
Changes in Axial Length
Measured: 90 and 180 days from baseline
Cumulative Incidence of Myopia
Measured: 90 and 180 days from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start1 Jun 2025
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This randomized controlled crossover trial was conducted in two sequential phases: Phase I (Day 0-90): Group A: Performed daily near-work activities (e.g., reading/writing) using the Virtual Far-sight Reading Device with cumulative daily use ≥60 minutes. Group B: Engaged in routine near-work activities without intervention. Phase II (Day 90-180): Group A: Switched to standard near-work practice without device use. Group B: Initiated Virtual Far-sight Reading Device intervention under identical protocol (≥60 min/day cumulative use).
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995911
- Sponsor's protocol ID
- YMZSSJLY202501
- Status last verified
- May 2026
- First submitted
- 21 May 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial on the Efficacy and Safety of the Virtual Far-sight Reading Device for Myopia Intervention in Pre-myopic Children
- ClinicalTrials.gov ID
- NCT06995911
- Acronym / sponsor ID
- YMZSSJLY202501
- Conditions
- Myopia, Pre-myopia
- Keywords
- Myopia, Pre-myopia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 30 May 2025 (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.
This clinical trial wants to find out if the Virtual Far-sight Reading Device can help prevent or slow down myopia progression in children and teenagers with pre-myopia. We also want to know what makes this treatment work better for some participants and check for any eye or body-related side effects over time.
Main questions:
Can using the Virtual Far-sight Reading Device reduce the risk of myopia? Is the device safe to use every day for up to 6 months?
What we'll do:
Researchers will compare two groups of children:
Group A: Uses the device for reading/writing (at least 1 hour daily) Group B: Does regular reading/writing without the device After 90 days, the groups will switch to see if the results stay the same.
Participants will:
- Have free eye checkups 3 times over 6 months
- Use the device during homework time (if in the desk group)
- Report any eye discomfort or problems
Detailed description
The Virtual Far-sight Reading Device is an innovative ocular protection device integrating advanced far-image optical technology, designed to alleviate asthenopia and prevent myopia progression by simulating a long-distance visual environment. Utilizing a birdbath optical configuration and freeform surface technology, it extends the working distance from 30 cm to over 6 meters, mimicking natural distance viewing to induce ciliary muscle relaxation. The device incorporates a cinematic-grade 2K true-color retinal display combined with a peripheral defocus optical design to generate hyperopic retinal shifts, thereby suppressing myopia development. Additional features include an embedded high-resolution AI camera, full-spectrum LED auxiliary lighting (CCT 5000K, CRI >90), and compatibility with extensive e-learning resources, making it suitable for diverse scenarios such as online classes, reading, and writing tasks.
This study employs a randomized controlled crossover trial to evaluate the efficacy and safety of the device in pre-myopic children and adolescents. Participants are divided into Groups A and B, with Phase I (Days 0-90) requiring Group A to perform daily near-work activities using the device for ≥60 minutes of cumulative daily use, while Group B follows conventional near-work practices without intervention. During Phase II (Days 91-180), the interventions are reversed between groups. Comprehensive ophthalmic evaluations are conducted at baseline, Day 90, and Day 180 to assess changes in spherical equivalent refraction (SER), axial length (AL), myopia incidence rate, binocular visual function parameters, and ocular morphological metrics, ensuring rigorous analysis of both therapeutic outcomes and safety profiles.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This randomized controlled crossover trial was conducted in two sequential phases: Phase I (Day 0-90): Group A: Performed daily near-work activities (e.g., reading/writing) using the Virtual Far-sight Reading Device with cumulative daily use ≥60 minutes. Group B: Engaged in routine near-work activities without intervention. Phase II (Day 90-180): Group A: Switched to standard near-work practice without device use. Group B: Initiated Virtual Far-sight Reading Device intervention under identical protocol (≥60 min/day cumulative use).
| Arm | Type | Receives |
|---|---|---|
| Nearwork with the Virtual Far-sight Reading Device | Experimental | Device: Virtual Far-sight Reading Device |
| Nearwork without the Virtual Far-sight Reading Device | No intervention | – |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age: 6-12 years (inclusive), gender unrestricted.
- ⑥ Compliance: Commitment to daily home use of the Far-Image Light Field Desk per protocol, immediate notification to investigators if unable to comply, and completion of scheduled follow-ups.
- ⑦ Informed consent: Signed assent form (minor) and written informed consent from legal guardian.
Key exclusion criteria (8 listed)
- Ocular comorbidities affecting vision/refractive development: Marfan syndrome; Lens pathologies (e.g., cataracts); Glaucoma; retinal detachment; retinopathy of prematurity
- ⑤ Medications affecting efficacy evaluation (within 3 months): Anticholinergics (e.g., atropine, pirenzepine); Cholinergics (e.g., pilocarpine)
- ⑥ Participation in other clinical trials within 3 months.
- ⑦ Contraindications/allergies to cycloplegics or study-related medications.
- ⑧ Chronic psychiatric disorders or cognitive impairment.
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 |
|---|---|---|
| Virtual Far-sight Reading DeviceThe Virtual Far-sight Reading Device utilizes a birdbath optical configuration and freeform surface technology to extend the working distance from 30 cm to over 6 meters, thereby simulating distance viewing conditions and maintaining ciliary muscle relaxation. Study participants were required to engage in reading and writing tasks using the device for a cumulative daily duration of at least 1 hour. | Device | Nearwork with the Virtual Far-sight Reading Device |
Primary outcome
Changes in Spherical Equivalent Refraction
Time frame: 90 and 180 days from baseline
2 secondary outcomes
Changes in Axial Length
Time frame: 90 and 180 days from baseline
Cumulative Incidence of Myopia
Time frame: 90 and 180 days from baseline
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 26 May 2026.
- Individual participant dataSharing planned: Undecided
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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 study testing Virtual Far-sight Reading Device in people with Myopia and Pre-myopia, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
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 5 inclusion and 8 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 26 May 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Wei Xu, Prof (+86 18521513008, vvxuwei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Spherical Equivalent Refraction (time frame: 90 and 180 days from baseline). 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 26 May 2026.