Dry EyeNCT04413370
Dry Eye Screening and Referral System
An observational study of Dry Eye, run by Sun Yat-sen University at 1 site in China.
Trial summary
Dry eye is one of the most common ocular surface diseases. Its pathogenic factors are related to multiple etiology. Because of the complexity of the pathogenesis of dry eye, the diversity of related examinations, and the inconsistency of symptoms and signs of dry eye patients, the diagnosis of dry eye has higher… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Dry eye diagnostic test
- How many people
- 1,273 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2020to 31 Jul 2024
- How long will I take part?
- 1 Day
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects who are equal or over 18 years old with or without dry eye symptoms and signs.
Who may be able to join
- Subjects whose age are greater than or equal to 18 years old;
- Subjects who can cooperate with the inspection;
- Subjects who agree to participate in the study and sign the consent form.
Who cannot join
- Subjects who cannot do the inspection.
- Subjects who suffer from diseases that compromise the inspection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Development of Artificial Intelligence Dry Eye Screening and Referral System
Dry eye is one of the most common ocular surface diseases. Its pathogenic factors are related to multiple etiology. Because of the complexity of the pathogenesis of dry eye, the diversity of related examinations, and the inconsistency of symptoms and signs of dry eye patients, the diagnosis of dry eye has higher requirements on the professional technology and examination equipment of ophthalmologists.
The purpose of this study is to establish a case-control cohort of dry eye patients. Multimodal data will be collected from participants, including medical history information, ocular surface disease index scale (OSDI), anterior segment photography, and treatment outcome of dry eye patients. The correlation between the characteristics of anterior segment images and dry eye diagnosis will be explored by artificial intelligence algorithms. The purpose of this study was to develop an artificial intelligence dry eye screening and referral system.
- Conditions
- Dry Eye
- Being tested
- Dry eye diagnostic test
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry eye diagnostic testDiagnostic test
The artificial intelligent dry eye screening platform
| Study group | Role | What they receive |
|---|---|---|
| Severe Group | This group of subjects needed a referral to the hospital for further treatments. Receives: Diagnostic Test: Dry eye diagnostic test | |
| Mild group | This group of subjects was diagnosed with dry eye but can use artificial tears instead of further treatment. Receives: Diagnostic Test: Dry eye diagnostic test | |
| Follow-up group | This group of subjects had no dry eye symptoms and signs and belonged to the normal control group. Receives: Diagnostic Test: Dry eye diagnostic test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (severe)
AUC values for predicting whether subject need to be referral or not.
Measured: up to 1 month
Secondary outcomes (2)
Area under the curve (each group)
AUC values for predicting whether subject can be accurately grouped into each of the four groups.
Measured: up to 1 month
Accuracy, true positive rate, and true negative rate
The performance of this artificial platform.
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start6 Jan 2020
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- 1,273 participants (actual)
- Target duration
- 1 Day
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413370
- Sponsor's protocol ID
- Dry eye screening system
- Status last verified
- Aug 2024
- First submitted
- 28 May 2020
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of Artificial Intelligence Dry Eye Screening and Referral System
- ClinicalTrials.gov ID
- NCT04413370
- Acronym / sponsor ID
- Dry eye screening system
- Conditions
- Dry Eye
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,273 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 2 Jun 2020 (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.
Dry eye is one of the most common ocular surface diseases. Its pathogenic factors are related to multiple etiology. Because of the complexity of the pathogenesis of dry eye, the diversity of related examinations, and the inconsistency of symptoms and signs of dry eye patients, the diagnosis of dry eye has higher requirements on the professional technology and examination equipment of ophthalmologists.
The purpose of this study is to establish a case-control cohort of dry eye patients. Multimodal data will be collected from participants, including medical history information, ocular surface disease index scale (OSDI), anterior segment photography, and treatment outcome of dry eye patients. The correlation between the characteristics of anterior segment images and dry eye diagnosis will be explored by artificial intelligence algorithms. The purpose of this study was to develop an artificial intelligence dry eye screening and referral system.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Severe Group | – | Diagnostic Test: Dry eye diagnostic testThis group of subjects needed a referral to the hospital for further treatments. |
| Mild group | – | Diagnostic Test: Dry eye diagnostic testThis group of subjects was diagnosed with dry eye but can use artificial tears instead of further treatment. |
| Follow-up group | – | Diagnostic Test: Dry eye diagnostic testThis group of subjects had no dry eye symptoms and signs and belonged to the normal control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are equal or over 18 years old with or without dry eye symptoms and signs.
Key inclusion criteria (3 listed)
- Subjects whose age are greater than or equal to 18 years old;
- Subjects who can cooperate with the inspection;
- Subjects who agree to participate in the study and sign the consent form.
Key exclusion criteria (2 listed)
- Subjects who cannot do the inspection.
- Subjects who suffer from diseases that compromise the inspection.
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 |
|---|---|---|
| Dry eye diagnostic testThe artificial intelligent dry eye screening platform | Diagnostic test | Follow-up group, Mild group, Severe Group |
Primary outcome
Area under the curve (severe)
Time frame: up to 1 month
AUC values for predicting whether subject need to be referral or not.
2 secondary outcomes
Area under the curve (each group)
Time frame: up to 1 month
Accuracy, true positive rate, and true negative rate
Time frame: up to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Dry Eye, 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 23 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (severe) (time frame: up to 1 month). 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 23 Sep 2026.