Myopia, ProgressiveDISNCT06088225
Myopia Preventing With Distance-image Screen
A study testing distance-image screen in people with Myopia, Progressive, run by Beijing Airdoc Technology Co., Ltd. at 1 site in China.
Trial summary
This study is for testing the efficacy and safety of distance-image screens for preventing myopia in children for 12 month. Each subjects would be asked to paired test the ocular parameters between before and after 12-month distance-image screens. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Progressive
- What is being tested?
- distance-image screen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 31 Dec 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
- Healthy volunteers accepted
- Child
Who may be able to join
- (1) Must be 6~12 years old;
- (2) Must be best corrected visual acuity < logMAR: 0.1;
- (3) Spherical Equivalence (SE) must be -1.00~ + 6.00 Diopter (D),
- (4) Spherical Equivalence (SE) must have changed > 1.25 Diopter (D) in the recent 2 years;
- (5) Must be astigmatism <1.75 Diopter (D);
- (6) Must be anisometropia <1.75 Diopter(D).
Who cannot join
- (1) Strabismus disease;
- (2) Amblyopia disease;
- (3) Cataract disease;
- (4) Glaucoma disease;
- (5) Severe dry eye disease;
- (6) Cannot use distance-image screen for 12 month;
- (7) Other severe diseases that would effect the use of distance-image screen.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Huadong AI, OD contact
China1 site, 1 recruiting
- Recruiting
Airdoc MPC Opthalmology Clinics
Beijing, Beijing Municipality, 100089
HUADONG Ai, OD, +8613811449846, drqiu666@126.com
QIU JENNY, +8618510386815, kkaiqiu@126.com
About this study
Official title: Clinically Study the Ocular Axial Length and Sphere Equivalence Changes of Children With Distance-image Screen Usage for One Year
This study is for testing the efficacy and safety of distance-image screens for preventing myopia in children for 12 month. Each subjects would be asked to paired test the ocular parameters between before and after 12-month distance-image screens.
Read the detailed description
This study is for testing the efficacy and safety of distance-image screens intended usage for preventing myopia in children with reading after a 6-meter-distant-image device. It was a prospective study. The investigators would like to recruit 100 volunteers, aged 6 years 16 in Beijing.
All the volunteers will be complete examined their ocular parameters before using the distant-image screen in a random order for at least 2 hours daily for 12 month. The changes of ocular axial length and refractive error were both calculated before and after 12-month usage for paired t-test.
- Conditions
- Myopia, Progressive
- Being tested
- distance-image screen
- Keywords
- Myopia; children
- Medical subject headings
- Myopia, Degenerative, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
distance-image screenDevice
Distance-image screen is a screen make each image at distance of 6-meters to reduce the accommodation and convergence for eyes during the reading and learning with screens.
| Study group | Role | What they receive |
|---|---|---|
| Distance -image screen | Experimental | Distance -image screen is a device to make image in the distance of 6-meters when reading and learning at near. The investigators will ask the subjects to use the distance - image screen for 12 month Receives: Device: distance-image screen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of ocular axial length (mm)
IntraOcularLens (IOL) master biometry will exam each eye before the testing and after the testing with distance-image screen
Measured: 12-month
Changes of refractive error (D)
Cycloplegic refraction with autorefractor will test each eye before the testing and after the testing with distance-image screen
Measured: 12-month
Secondary outcomes (3)
Changes of center macular thickness (um)
Optic Coherent Topograph (OCT) of macular fovea central thickness will be made to compare the thickness before and after using distance-image screen
Measured: 12-month
Changes of subretina choroidal thickness (um)
Optic Coherent Topograph (OCT) with Enhanced Depth Imaging (EDI) scan of macular fovea central thickness will be done to compare the thickness before and after using distance-image screen
Measured: at 12-month
Changes of other regions choroidal thickness (um)
Optic Coherent Topograph (OCT) with Enhanced Depth Imaging (EDI) scan of other regions choroidal thickness will be done to compare the thickness before and after using distance-image screen
Measured: 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start1 Oct 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia, ProgressiveStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Paired testing those ocular parameters before and after 12-month usage of distance-image screen
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Airdoc Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088225
- Sponsor's protocol ID
- Beijing Airdoc MPC Co., Ltd.
- Acronym
- DIS
- Status last verified
- Oct 2023
- First submitted
- 12 Oct 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinically Study the Ocular Axial Length and Sphere Equivalence Changes of Children With Distance-image Screen Usage for One Year
- ClinicalTrials.gov ID
- NCT06088225
- Acronym / sponsor ID
- DIS / Beijing Airdoc MPC Co., Ltd.
- Conditions
- Myopia, Progressive
- Keywords
- Myopia; children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing Airdoc Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Oct 2023 (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 study is for testing the efficacy and safety of distance-image screens for preventing myopia in children for 12 month. Each subjects would be asked to paired test the ocular parameters between before and after 12-month distance-image screens.
Detailed description
This study is for testing the efficacy and safety of distance-image screens intended usage for preventing myopia in children with reading after a 6-meter-distant-image device. It was a prospective study. The investigators would like to recruit 100 volunteers, aged 6 years 16 in Beijing.
All the volunteers will be complete examined their ocular parameters before using the distant-image screen in a random order for at least 2 hours daily for 12 month. The changes of ocular axial length and refractive error were both calculated before and after 12-month usage for paired t-test.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Paired testing those ocular parameters before and after 12-month usage of distance-image screen
| Arm | Type | Receives |
|---|---|---|
| Distance -image screen | Experimental | Device: distance-image screenDistance -image screen is a device to make image in the distance of 6-meters when reading and learning at near. The investigators will ask the subjects to use the distance - image screen for 12 month |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- (1) Must be 6~12 years old;
- (2) Must be best corrected visual acuity < logMAR: 0.1;
- (3) Spherical Equivalence (SE) must be -1.00~ + 6.00 Diopter (D),
- (4) Spherical Equivalence (SE) must have changed > 1.25 Diopter (D) in the recent 2 years;
- (5) Must be astigmatism <1.75 Diopter (D);
Key exclusion criteria (7 listed)
- (1) Strabismus disease;
- (2) Amblyopia disease;
- (3) Cataract disease;
- (4) Glaucoma disease;
- (5) Severe dry eye disease;
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 |
|---|---|---|
| distance-image screenDistance-image screen is a screen make each image at distance of 6-meters to reduce the accommodation and convergence for eyes during the reading and learning with screens. | Device | Distance -image screen |
Primary outcome
Changes of ocular axial length (mm)
Time frame: 12-month
IntraOcularLens (IOL) master biometry will exam each eye before the testing and after the testing with distance-image screen
Changes of refractive error (D)
Time frame: 12-month
Cycloplegic refraction with autorefractor will test each eye before the testing and after the testing with distance-image screen
3 secondary outcomes
Changes of center macular thickness (um)
Time frame: 12-month
Changes of subretina choroidal thickness (um)
Time frame: at 12-month
Changes of other regions choroidal thickness (um)
Time frame: 12-month
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 24 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Huadong AI, OD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing distance-image screen in people with Myopia, Progressive, run by Beijing Airdoc Technology Co., Ltd. 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 6 inclusion and 7 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 24 Oct 2023. 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 QIU JENNY, MD (+8618510386815, kkaiqiu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of ocular axial length (mm) (time frame: 12-month). The study lists 2 primary outcomes in all. 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 24 Oct 2023.