OphthalmologyAINCT04919837
The Efficacy of an Artificial Intelligence Platform to Adapt Visual Aids for Patients With Low Vision: a Randomised Controlled Trial
A study testing Low vision aids in people with Ophthalmology and Low Vision Aids, run by Sun Yat-sen University at 1 site in China.
Trial summary
According to the WHO's definition of visual impairment, as of 2018, there were approximately 1.3 billion people with visual impairment in the world, and only 10% of countries can provide assisting services for the rehabilitation of visual impairment. Read more about this study
- Who is it for?
- Ages 3 to 105 years
- Conditions the study is for
- Ophthalmology, Low Vision Aids, Artificial Intelligence
- What is being tested?
- Low vision aids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 27 Jul 2020to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 105 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Low vision Aged 3 to 105
Who cannot join
- Severe systemic diseases Failure to sign informed consent or unwilling to participate
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affilliated Hospital of Jujian Medical University
Quanzhou, Fujian, 362000
Jianmin Hu, M.D., Ph.D., +8615359595888, doctorhjm@163.com
About this study
According to the WHO's definition of visual impairment, as of 2018, there were approximately 1.3 billion people with visual impairment in the world, and only 10% of countries can provide assisting services for the rehabilitation of visual impairment. Although China is one of the countries that can provide rehabilitation services for patients with visual impairment, due to restrictions on the number of professionals in various regions, uneven diagnosis and treatment, and regional differences in economic conditions, not all visually impaired patients can get the rehabilitation of assisting device fitting.
Traditional statistical methods were not enough to solve the problem of intelligent fitting of assisting devices. At present, there are almost no intelligent fitting models of assisting devices in the world. Therefore, in order to allow more low-vision patients to receive accurate and rapid rehabilitation services, we conducted a cross-sectional study on the assisting devices fitting for low-vision patients in Fujian Province, China in the past five years, and at the same time constructed a machine learning model to intelligently predict the adaptation result of the basic assisting devices for low vision patients.
- Conditions
- Ophthalmology, Low Vision Aids, Artificial Intelligence
- Being tested
- Low vision aids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low vision aidsOther
the assisting devices fitting for low-vision patients
| Study group | Role | What they receive |
|---|---|---|
| Algorithm assisted group | Experimental | Patients receive assisting devices fitting services from human doctors assisted by the machine learning model Receives: Other: Low vision aids |
| Human doctor group | Experimental | Patients receive assisting devices fitting services from humanr doctors Receives: Other: Low vision aids |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of giving up assisting devices
The investigator will calculate the proportion of giving up more than one assisting devices in two groups for three months and six months
Measured: Baseline
Secondary outcomes (1)
Time cost of using assisting devices of patients
The investigator will apply survival analysis for the time cost of using assisting devices in different groups.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start27 Jul 2020
- Primary completion27 Jul 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OphthalmologyStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- 2nd Affilliated Hospital of Fujian Medical University
- Responsible party
- Principal investigator, Haotian Lin, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919837
- Sponsor's protocol ID
- SFLVRCT-2020
- Acronym
- AI
- Status last verified
- Jun 2021
- First submitted
- 6 Jun 2021
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of an Artificial Intelligence Platform to Adapt Visual Aids for Patients With Low Vision: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04919837
- Acronym / sponsor ID
- AI / SFLVRCT-2020
- Conditions
- Ophthalmology, Low Vision Aids, Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- 2nd Affilliated Hospital of Fujian Medical University
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 27 Jul 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 9 Jun 2021 (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.
According to the WHO's definition of visual impairment, as of 2018, there were approximately 1.3 billion people with visual impairment in the world, and only 10% of countries can provide assisting services for the rehabilitation of visual impairment. Although China is one of the countries that can provide rehabilitation services for patients with visual impairment, due to restrictions on the number of professionals in various regions, uneven diagnosis and treatment, and regional differences in economic conditions, not all visually impaired patients can get the rehabilitation of assisting device fitting.
Traditional statistical methods were not enough to solve the problem of intelligent fitting of assisting devices. At present, there are almost no intelligent fitting models of assisting devices in the world. Therefore, in order to allow more low-vision patients to receive accurate and rapid rehabilitation services, we conducted a cross-sectional study on the assisting devices fitting for low-vision patients in Fujian Province, China in the past five years, and at the same time constructed a machine learning model to intelligently predict the adaptation result of the basic assisting devices for low vision patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Algorithm assisted group | Experimental | Other: Low vision aidsPatients receive assisting devices fitting services from human doctors assisted by the machine learning model |
| Human doctor group | Experimental | Other: Low vision aidsPatients receive assisting devices fitting services from humanr doctors |
Who may qualify
- Ages
- 3 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Low vision Aged 3 to 105
Key exclusion criteria (1 listed)
- Severe systemic diseases Failure to sign informed consent or unwilling to participate
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 |
|---|---|---|
| Low vision aidsthe assisting devices fitting for low-vision patients | Other | Algorithm assisted group, Human doctor group |
Primary outcome
The proportion of giving up assisting devices
Time frame: Baseline
The investigator will calculate the proportion of giving up more than one assisting devices in two groups for three months and six months
1 secondary outcome
Time cost of using assisting devices of patients
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low vision aids in people with Ophthalmology and Low Vision Aids, run by Sun Yat-sen University 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Jun 2021. 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?
Results are not available in the source record.
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?
The proportion of giving up assisting devices (time frame: 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 9 Jun 2021.