MyopiaSRMRNCT06059521
Software Refraction With Mobilerone Versus Retinoscopy
A study testing Software refraction with Eye Test Technology in a mobilerone and Retinoscopy in people with Myopia and Myopia, Moderate, run by Beijing Airdoc Technology Co., Ltd. at 3 sites in China.
Trial summary
Software refraction in the mobilerone for myopia and astigmatism is a novel medical device for myopia adults and elder children with or without astigmatism. And the investigators would like to test its accuracy and efficacy as well as safety. Read more about this study
- Who is it for?
- Ages 10 to 46 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Myopia, Moderate, Astigmatism
- What is being tested?
- Software refraction with Eye Test Technology in a mobilerone and Retinoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesChina
- Study dates
- 15 Jul 2023to 30 Dec 2030
- 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 10 to 46 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- • subject with ametropia on each eye ≤-12.00D
- subject with best corrected visual acuity ≥ 20/25, no amblyopia
- subject with normal transparency of eyes
- subject with a healthy fundus that does not reveal major abnormalities that may affect vision due to the fluctuate situations
- subject able to cooperate with the screen and the operator
- subject without heavy drug treatment that may affect vision as synthetic antimalarials, corticosteroids
Show all 10Show fewer
- non-diabetic subject
- non nystagmus subject
- non-strabismus subject
- subject who has not had eye surgery less than 1 year old
Who cannot join
- • subject with a topography showing an anomaly (keratoconus type or other)
- subject with hyperopia or presbyopia
- subject with mild myopia ≥ -1.00D
- subject who cannot speak with the operator including those staff of local optometrists or ophthalmologists
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Not yet recruiting
Airdoc MPC Opthalmology Clinics
Beijing, Beijing Municipality, 100089
David, OD, +8618510386815, davidcoveney69@gmail.com
- Recruiting
Jenny QIU
Beijing, Beijing Municipality, 100089
Jenny QIU, MD, +8618510386815, qiukaikai0620@airdoc.com
- Recruiting
Qiu Jenny
Beijing, Haidian District, 100089
QIU JENNY, MD, +8618510386815, qiukaikai0620@airdoc.com
About this study
Official title: Randomized Controlled Study on Subjective Refraction by Software Eye Test Technology Versus Retinoscopy
Software refraction in the mobilerone for myopia and astigmatism is a novel medical device for myopia adults and elder children with or without astigmatism. And the investigators would like to test its accuracy and efficacy as well as safety.
Read the detailed description
It's a software installed in a mobilerone with subjective guide on screen for testing myopic refractive error with or without astigmatism for adults or elder children. The investigators would like to compare its refraction results with retinoscopy.
- Conditions
- Myopia, Myopia, Moderate, Astigmatism
- Being tested
- Software refraction with Eye Test Technology in a mobilerone, Retinoscopy
- Keywords
- software, refraction, subjective refraction, mobilerone, myopia, astigmatism
- Medical subject headings
- Myopia, Lymphoma, Follicular, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Software refraction with Eye Test Technology in a mobileroneDevice
Also called Online refraction or App refraction with Eye Test Technology
Refraction is done by software App by a mobilerone software installed.
RetinoscopyDevice
Also called Refraction by retinoscopy
Retinoscopy is an objective refraction method with retinoscope.
| Study group | Role | What they receive |
|---|---|---|
| Software Refraction | Experimental | Refraction is done by software with subjective refraction through a mobilerone. Receives: Device: Software refraction with Eye Test Technology in a mobilerone |
| Refraction by retinoscopy | Active comparator | Refraction is done objectively by retinoscopy. Receives: Device: Retinoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spherical Equivalence(D)
Spherical is myopic equivalence with total spherical plus half the cylinder diopter.
Measured: 1-day and within 2 weeks
Astigmatism Power(D)
Cylinder value of each total astigmatism power
Measured: 1-day and within 2 weeks
Astigmatism axial
Cylinder axis of astigmatism
Measured: 1-day and within 2 weeks
pupil distance (mm)
pupil distance measurement with software or autorefractor
Measured: 1-day and within 2 weeks
Secondary outcomes (1)
Efficacy of test time (minutes)
How long for each test
Measured: 1-day and within 2 eeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start15 Jul 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2030 (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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Airdoc Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Notre Dame Australia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059521
- Sponsor's protocol ID
- AirdocSoftwareEyeTest
- Acronym
- SRMR
- Status last verified
- Sep 2023
- First submitted
- 24 Jul 2023
- Last updated
- 28 Sep 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 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study on Subjective Refraction by Software Eye Test Technology Versus Retinoscopy
- ClinicalTrials.gov ID
- NCT06059521
- Acronym / sponsor ID
- SRMR / AirdocSoftwareEyeTest
- Conditions
- Myopia, Myopia, Moderate, Astigmatism
- Keywords
- software, refraction, subjective refraction, mobilerone, myopia, astigmatism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Beijing Airdoc Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- University of Notre Dame Australia
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 28 Sep 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.
Software refraction in the mobilerone for myopia and astigmatism is a novel medical device for myopia adults and elder children with or without astigmatism. And the investigators would like to test its accuracy and efficacy as well as safety.
Detailed description
It's a software installed in a mobilerone with subjective guide on screen for testing myopic refractive error with or without astigmatism for adults or elder children. The investigators would like to compare its refraction results with retinoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Software Refraction | Experimental | Device: Software refraction with Eye Test Technology in a mobileroneRefraction is done by software with subjective refraction through a mobilerone. |
| Refraction by retinoscopy | Active comparator | Device: RetinoscopyRefraction is done objectively by retinoscopy. |
Who may qualify
- Ages
- 10 to 46 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- • subject with ametropia on each eye ≤-12.00D
Key exclusion criteria (4 listed)
- • subject with a topography showing an anomaly (keratoconus type or other)
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 |
|---|---|---|
| Software refraction with Eye Test Technology in a mobileroneAlso: Online refraction or App refraction with Eye Test TechnologyRefraction is done by software App by a mobilerone software installed. | Device | Software Refraction |
| RetinoscopyAlso: Refraction by retinoscopyRetinoscopy is an objective refraction method with retinoscope. | Device | Refraction by retinoscopy |
Primary outcome
Spherical Equivalence(D)
Time frame: 1-day and within 2 weeks
Spherical is myopic equivalence with total spherical plus half the cylinder diopter.
Astigmatism Power(D)
Time frame: 1-day and within 2 weeks
Cylinder value of each total astigmatism power
Astigmatism axial
Time frame: 1-day and within 2 weeks
Cylinder axis of astigmatism
pupil distance (mm)
Time frame: 1-day and within 2 weeks
pupil distance measurement with software or autorefractor
1 secondary outcome
Efficacy of test time (minutes)
Time frame: 1-day and within 2 eeks
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 28 Sep 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Software refraction with Eye Test Technology in a mobilerone and Retinoscopy in people with Myopia and Myopia, Moderate, run by Beijing Airdoc Technology Co., Ltd. at 3 sites 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 10 inclusion and 4 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 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spherical Equivalence(D) (time frame: 1-day and within 2 weeks). The study lists 4 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 28 Sep 2023.