Catarct ScreeningAINCT05204095
Intelligent Cataract Screening With Portable Slit-lamp
An observational study of Catarct Screening and Artificial Intelligence, run by Sun Yat-sen University at 1 site in China.
Trial summary
Based on the portable slit-lamp connected to the smartphone, the artificial intelligence machine learning algorithm is used to establish a cataract screening model by prospectively collecting the anterior segment photographic data, and a portable slit lamp intelligent screening referral model based on the smartphone… Read more about this study
- Who is it for?
- Ages Up to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Catarct Screening, Artificial Intelligence
- What is being tested?
- Portable slit-lamp photography
- Type of treatment
- Medical device
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2022to 30 Jun 2023
- Phase
- Observational
- 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 Up to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The prospective population aged 0 to 100 with or without senile cataracts and received ocular examination.
Who may be able to join
- 0 to 100 years old
Who cannot join
- (1) History of eye disease except for age-related cataracts (2) History of eye trauma or eye surgery (3) Unable to cooperate with ophthalmology and general examination (4) Individuals with incomplete information (5) Unwilling to participate in this study
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
Guangzhou, Guangdong, 510060
Haotain Lin, M.D., Ph.D., +86-020-87330274, gddlht@aliyun.com
About this study
Based on the portable slit-lamp connected to the smartphone, the artificial intelligence machine learning algorithm is used to establish a cataract screening model by prospectively collecting the anterior segment photographic data, and a portable slit lamp intelligent screening referral model based on the smartphone connection is also established.
- Conditions
- Catarct Screening, Artificial Intelligence
- Being tested
- Portable slit-lamp photography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable slit-lamp photographyDevice
The enrolled patients will undergo portable slit-lamp photography with and without mydriasis and receive traditional slit-lamp photography for comparison.
| Study group | Role | What they receive |
|---|---|---|
| Referral group | The patients with severe cataracts in this group need a referral to a higher-level hospital for further treatment. Receives: Device: Portable slit-lamp photography | |
| Observation group | The patients with mild cataracts or transparent lenses in this group do not need a referral to a higher-level hospital for further treatment and keep regular examinations. Receives: Device: Portable slit-lamp photography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of referral
The accuracy of referral of AI model will be calculated with the decisions based on the portable slit-lamp images with reference to the ground truth.
Measured: Baseline
Secondary outcomes (1)
The accuracy of cataract diagnosis
The accuracy of cataract diagnosis of AI model will be calculated with the decisions based on the portable slit-lamp images with reference to the ground truth.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start10 Feb 2022 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catarct ScreeningStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haotian Lin, Sun Yat-sen University
- Investigators
- Yizhi Liu, M.D., Ph.D., Study chair, Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204095
- Sponsor's protocol ID
- SLCS-2022
- Acronym
- AI
- Status last verified
- Jan 2022
- First submitted
- 10 Jan 2022
- Last updated
- 24 Jan 2022
- 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 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intelligent Cataract Screening With Portable Slit-lamp
- ClinicalTrials.gov ID
- NCT05204095
- Acronym / sponsor ID
- AI / SLCS-2022
- Conditions
- Catarct Screening, Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 Feb 2022 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 24 Jan 2022 (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.
Based on the portable slit-lamp connected to the smartphone, the artificial intelligence machine learning algorithm is used to establish a cataract screening model by prospectively collecting the anterior segment photographic data, and a portable slit lamp intelligent screening referral model based on the smartphone connection is also established.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Referral group | – | Device: Portable slit-lamp photographyThe patients with severe cataracts in this group need a referral to a higher-level hospital for further treatment. |
| Observation group | – | Device: Portable slit-lamp photographyThe patients with mild cataracts or transparent lenses in this group do not need a referral to a higher-level hospital for further treatment and keep regular examinations. |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The prospective population aged 0 to 100 with or without senile cataracts and received ocular examination.
Key inclusion criteria (1 listed)
- 0 to 100 years old
Key exclusion criteria (1 listed)
- (1) History of eye disease except for age-related cataracts (2) History of eye trauma or eye surgery (3) Unable to cooperate with ophthalmology and general examination (4) Individuals with incomplete information (5) Unwilling to participate in this study
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 |
|---|---|---|
| Portable slit-lamp photographyThe enrolled patients will undergo portable slit-lamp photography with and without mydriasis and receive traditional slit-lamp photography for comparison. | Device | Observation group, Referral group |
Primary outcome
The accuracy of referral
Time frame: Baseline
The accuracy of referral of AI model will be calculated with the decisions based on the portable slit-lamp images with reference to the ground truth.
1 secondary outcome
The accuracy of cataract diagnosis
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 24 Jan 2022.
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.
Yizhi Liu, M.D., Ph.D. study chair
Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Catarct Screening and Artificial Intelligence, 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 24 Jan 2022. 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?
Contact Haotian Lin, M.D., Ph.D. (+86-020-87330274, gddlht@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of referral (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 24 Jan 2022.