Dry EyeNCT07614347
Development and Evaluation of an Intelligent Diagnosis System for Dry Eye Disease Based on Confocal Microscopy
An observational study of Dry Eye, run by Capital Medical University.
Trial summary
Dry eye disease is a major ophthalmic health issue that severely affects the visual function and quality of life of the national population. Its core pathological mechanism involves a vicious cycle of ocular surface inflammation and neural abnormalities; however, clinical practice still lacks an objective and… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dry Eye
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 31 Dec 2028
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- Adult
Study population: This study intends to include patients with dry eye and healthy controls as the research subjects.
Who may be able to join
- Normal group:
- Healthy adults aged 18 to 60;
- OSDI score of ocular surface disease Index <13 points;
- Good tear film stability (tear film break-up time TBUT≥10 seconds) and negative corneal fluorescein staining;
- Dry eye Group:
- Healthy adults aged 18 to 60;
- Tear film break-up time ≤5 seconds or SchirmerⅠ≤5mm/5min without surface anesthesia, with one of the subjective symptoms such as dryness, foreign body sensation, burning sensation, fatigue, discomfort, or vision fluctuation in the eyes;
- 5 <Tear film break-up time ≤10 seconds or 5mm/5 min/less under no surface anesthesia; When SchirmerⅠ is ≤10 mm/5min, there is one of the subjective symptoms in the eyes, such as dryness, foreign body sensation, burning sensation, fatigue, discomfort, and vision fluctuation. At the same time, the fluorescein staining of the cornea and conjunctiva is positive.
Who cannot join
- Combined with systemic diseases or neurological diseases that may affect corneal nerve function;
- Having used any local anti-inflammatory drugs for the eyes within 2 weeks before enrollment or having a history of wearing contact lenses within 3 months;
- Other eye diseases besides dry eye and history of eye surgery;
About this study
Dry eye disease is a major ophthalmic health issue that severely affects the visual function and quality of life of the national population. Its core pathological mechanism involves a vicious cycle of ocular surface inflammation and neural abnormalities; however, clinical practice still lacks an objective and quantitative gold standard for diagnosis. Although in vivo confocal microscopy (IVCM) enables cellular-level, in vivo observation of the ocular surface, image analysis remains heavily dependent on manual interpretation, highlighting an urgent need for an intelligent quantitative framework.This project aims to construct a high-quality, standardized ocular surface imaging database and develop a high-precision deep learning algorithm to achieve accurate segmentation and quantification of corneal nerves (including both whorl-like and linear patterns) and inflammatory cells, and to validate their associations with clinical indicators of dry eye disease. The ultimate goal is to develop and evaluate an IVCM-based multimodal intelligent diagnostic system for dry eye, transforming IVCM from an observational tool into an intelligent decision-support system, with real-world performance validated through an independent prospective cohort.This project is expected to establish a multimodal AI diagnostic model for dry eye, create a standardized computational framework for imaging biomarkers, and enable a paradigm shift from qualitative description to quantitative diagnosis. The findings will provide reliable decision-making support for precision subtyping and personalized treatment of dry eye disease, advancing ophthalmic practice toward a data-driven, intelligent paradigm.
- Conditions
- Dry Eye
- 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.
| Study group | Role | What they receive |
|---|---|---|
| dry eye group | Not described | |
| control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
in vivo confocal microscopy examination
Images of the central corneal area and the inferior thread area of the patients were collected using in vivo confocal microscopy. During the examination, the patient's lower jaw is placed on the bracket, the forehead is tightly against the frontal support, and the patient is fixated on the target. A corneal contact probe is used. After applying Carbomer gel, it touches the corneal surface and scans layer by layer to obtain images of each layer of the cornea. The clear images of the linear nerves in the central area of the cornea and the vortex-like nerves in the lower vortex-like area were mainly collected for the subsequent intelligent analysis system to extract the morphological parameters of the corneal nerves and the parameters of inflammatory cells.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
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 Capital Medical 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
- Cross-sectional
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Chen, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614347
- Sponsor's protocol ID
- TREC2026-KY070
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of an Intelligent Diagnosis System for Dry Eye Disease Based on Confocal Microscopy
- ClinicalTrials.gov ID
- NCT07614347
- Acronym / sponsor ID
- TREC2026-KY070
- Conditions
- Dry Eye
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 May 2026 (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 disease is a major ophthalmic health issue that severely affects the visual function and quality of life of the national population. Its core pathological mechanism involves a vicious cycle of ocular surface inflammation and neural abnormalities; however, clinical practice still lacks an objective and quantitative gold standard for diagnosis. Although in vivo confocal microscopy (IVCM) enables cellular-level, in vivo observation of the ocular surface, image analysis remains heavily dependent on manual interpretation, highlighting an urgent need for an intelligent quantitative framework.This project aims to construct a high-quality, standardized ocular surface imaging database and develop a high-precision deep learning algorithm to achieve accurate segmentation and quantification of corneal nerves (including both whorl-like and linear patterns) and inflammatory cells, and to validate their associations with clinical indicators of dry eye disease. The ultimate goal is to develop and evaluate an IVCM-based multimodal intelligent diagnostic system for dry eye, transforming IVCM from an observational tool into an intelligent decision-support system, with real-world performance validated through an independent prospective cohort.This project is expected to establish a multimodal AI diagnostic model for dry eye, create a standardized computational framework for imaging biomarkers, and enable a paradigm shift from qualitative description to quantitative diagnosis. The findings will provide reliable decision-making support for precision subtyping and personalized treatment of dry eye disease, advancing ophthalmic practice toward a data-driven, intelligent paradigm.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dry eye group | – | – |
| control group | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- This study intends to include patients with dry eye and healthy controls as the research subjects.
Key inclusion criteria (8 listed)
- Healthy adults aged 18 to 60;
- OSDI score of ocular surface disease Index <13 points;
- Good tear film stability (tear film break-up time TBUT≥10 seconds) and negative corneal fluorescein staining;
- Healthy adults aged 18 to 60;
- Tear film break-up time ≤5 seconds or SchirmerⅠ≤5mm/5min without surface anesthesia, with one of the subjective symptoms such as dryness, foreign body sensation, burning sensation, fatigue, discomfort, or vision fluctuation in the eyes;
Key exclusion criteria (3 listed)
- Combined with systemic diseases or neurological diseases that may affect corneal nerve function;
- Having used any local anti-inflammatory drugs for the eyes within 2 weeks before enrollment or having a history of wearing contact lenses within 3 months;
- Other eye diseases besides dry eye and history of eye surgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
in vivo confocal microscopy examination
Time frame: Baseline
Images of the central corneal area and the inferior thread area of the patients were collected using in vivo confocal microscopy. During the examination, the patient's lower jaw is placed on the bracket, the forehead is tightly against the frontal support, and the patient is fixated on the target. A corneal contact probe is used. After applying Carbomer gel, it touches the corneal surface and scans layer by layer to obtain images of each layer of the cornea. The clear images of the linear nerves in the central area of the cornea and the vortex-like nerves in the lower vortex-like area were mainly collected for the subsequent intelligent analysis system to extract the morphological parameters of the corneal nerves and the parameters of inflammatory cells.
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 29 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye, run by Capital Medical University.
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 8 inclusion and 3 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: opening soon, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
in vivo confocal microscopy examination (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 29 May 2026.