Ocular Surface DiseaseNCT07628946
Establishment of a Multimodal Standard Database for Inflammation-related Ophthalmopathy
An observational study of Ocular Surface Disease and Inflammatory Disease, run by Dan Chen at 1 site in China.
Trial summary
Through a systematic observational study, the intrinsic connections and patterns between the occurrence and development of common blinding retinal diseases such as diabetic retinopathy, pathological myopia, and age-related macular degeneration and the changes in fine parameters of the anterior structure of the eye are… Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Ocular Surface Disease, Inflammatory Disease, Retinal Disease
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 26 Nov 2025to Feb 2030
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population includes patients with both inflammatory and non-inflammatory ocular diseases.
Who may be able to join
- Retinal vascular and metabolic-related diseases: Diabetic Retinopathy (DR, including NPDR and PDR), Retinal Vein Occlusion (RVO), Hypertensive Retinopathy.
- Degenerative diseases: Age-related Macular Degeneration (including dry and wet forms), Pathologic Myopia (PM), Polypoidal Choroidal Vasculopathy (PCV).
- Immune-mediated and inflammatory eye diseases: Uveitis (including primary and secondary), Optic Neuritis, Mooren's Ulcer, and corneal melting associated with systemic immune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus).
- Anterior segment and ocular surface syndromes: Various types of Dry Eye Disease (DED), Keratoconus, Glaucoma (especially cases with chronic inflammation or long-term medication use).
- Developmental fundus diseases in children and adolescents: Coats' Disease, Familial Exudative Vitreoretinopathy (FEVR), Retinopathy of Prematurity (ROP).
- Patients with a confirmed diagnosis of fundus diseases, including Diabetic Retinopathy, Pathologic Myopia, Age-related Macular Degeneration, Coats' Disease, Familial Exudative Vitreoretinopathy (FEVR), Retinopathy of Prematurity (ROP), and other adult or pediatric fundus diseases.
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- Ability to cooperate with study examinations, including acceptance of Ultra-Widefield (UWF) fundus photography, OCT/OCTA, AOSLO, corneal confocal microscopy, meibomian gland function assessment, corneal esthesiometry, and tear film function tests. Image quality must meet analytical standards.
- Availability of complete or follow-up accessible ophthalmic medical records.
- Blood pressure ≤ 160/100 mmHg (to avoid exacerbating ischemia due to uncontrolled hypertension).
Who cannot join
- Recent (within the past 3 months) corneal/conjunctival acute inflammation, ocular surgery, or ocular trauma; or presence of corneal alterations (e.g., contact lens wear).
- Fundus images that are uninterpretable or severely obscured (e.g., vitreous hemorrhage).
- Use of medications affecting tear secretion (e.g., antihistamines, antidepressants) within the past 30 days.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tongren Hospital
Beijing
Jin Yuan, +86 13825141659, yuanjincornea@126.com
About this study
Through a systematic observational study, the intrinsic connections and patterns between the occurrence and development of common blinding retinal diseases such as diabetic retinopathy, pathological myopia, and age-related macular degeneration and the changes in fine parameters of the anterior structure of the eye are deeply explored. To achieve this goal, investigators will adopt cutting-edge multimodal imaging technology to simultaneously collect precise data from ocular surface and fundus of participants. By integrating and analyzing these multi-dimensional information from different parts of the same eye, investigators will build a high-quality and standardized ocular surface-fundus associated image database. This database not only aims to reveal potential ocular surface biomarkers that can be used for early warning or auxiliary diagnosis, but also lays a solid data foundation for the future development of artificial intelligence-assisted diagnostic tools and the establishment of a brand-new ocular surface-fundus integrated diagnosis and treatment assessment model.
- Medical subject headings
- Retinal Diseases, Choroid Diseases
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 |
|---|---|---|
| Inflammatory-Related Ocular Disease Group | Not described | |
| Non-Inflammatory-Related Ocular Disease Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear Break-Up Time
The time from the last complete blink to the appearance of the first dry spot on the cornea.
Measured: Baseline and within 30 days post-procedure
Dry Eye Questionnaire-5
The DEQ-5 comprises five items assessing the frequency of dryness, discomfort, and watery eyes, as well as the late-day intensity of dryness and discomfort. Patients rate each item on a 0-4 or 0-5 scale, and the total score is summed. Higher scores indicate greater dry eye symptom severity.
Measured: Baseline and within 30 days post-procedure
Meibomian Gland Dropout
Meibomian gland dropout will be measured using infrared meibography.
Measured: Baseline and within 30 days post-procedure
Blink Rate
Blink rate will be measured using a video recording system under natural blinking conditions. The number of complete blinks and incomplete blinks per minute will be counted separately.
Measured: Baseline and within 30 days post-procedure
Lipid Layer Thickness
Lipid layer thickness refers to the thickness of the lipid layer of the tear film, which is the outermost layer of the precorneal tear film.
Measured: Baseline and within 30 days post-procedure
Tear Meniscus Height
Tear meniscus height refers to the vertical height of the tear volume accumulated along the lower eyelid margin.
Measured: Baseline and within 30 days post-procedure
Secondary outcomes (5)
Central Subfield Thickness
Central subfield thickness refers to the thickness of the retina at the fovea.
Measured: Baseline and within 30 days post-procedure
Subfoveal Choroidal Thickness
Subfoveal choroidal thickness refers to the thickness of the choroid directly beneath the fovea.
Measured: Baseline and within 30 days post-procedure
Subretinal Fluid
Subretinal fluid refers to fluid accumulation in the potential space between the neurosensory retina and the retinal pigment epithelium.
Measured: Baseline and within 30 days post-procedure
Intraretinal Fluid
Intraretinal fluid refers to fluid accumulation within the retinal layers, typically appearing as cystoid spaces.
Measured: Baseline and within 30 days post-procedure
Pigment Epithelial Detachment Height
Pigment epithelial detachment height refers to the maximal vertical height of separation of the retinal pigment epithelium from the underlying Bruch's membrane.
Measured: Baseline and within 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start26 Nov 2025
- Primary completionFeb 2030 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Surface DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dan Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dan Chen, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07628946
- Sponsor's protocol ID
- TREC2026-KY044
- Status last verified
- Jun 2026
- First submitted
- 26 May 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Multimodal Standard Database for Inflammation-related Ophthalmopathy
- ClinicalTrials.gov ID
- NCT07628946
- Acronym / sponsor ID
- TREC2026-KY044
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Dan ChenUniversity, hospital or other
- Study start
- 26 Nov 2025 (actual)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 5 Jun 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.
Through a systematic observational study, the intrinsic connections and patterns between the occurrence and development of common blinding retinal diseases such as diabetic retinopathy, pathological myopia, and age-related macular degeneration and the changes in fine parameters of the anterior structure of the eye are deeply explored. To achieve this goal, investigators will adopt cutting-edge multimodal imaging technology to simultaneously collect precise data from ocular surface and fundus of participants. By integrating and analyzing these multi-dimensional information from different parts of the same eye, investigators will build a high-quality and standardized ocular surface-fundus associated image database. This database not only aims to reveal potential ocular surface biomarkers that can be used for early warning or auxiliary diagnosis, but also lays a solid data foundation for the future development of artificial intelligence-assisted diagnostic tools and the establishment of a brand-new ocular surface-fundus integrated diagnosis and treatment assessment model.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inflammatory-Related Ocular Disease Group | – | – |
| Non-Inflammatory-Related Ocular Disease Group | – | – |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population includes patients with both inflammatory and non-inflammatory ocular diseases.
Key inclusion criteria (9 listed)
- Retinal vascular and metabolic-related diseases: Diabetic Retinopathy (DR, including NPDR and PDR), Retinal Vein Occlusion (RVO), Hypertensive Retinopathy.
- Degenerative diseases: Age-related Macular Degeneration (including dry and wet forms), Pathologic Myopia (PM), Polypoidal Choroidal Vasculopathy (PCV).
- Immune-mediated and inflammatory eye diseases: Uveitis (including primary and secondary), Optic Neuritis, Mooren's Ulcer, and corneal melting associated with systemic immune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus).
- Anterior segment and ocular surface syndromes: Various types of Dry Eye Disease (DED), Keratoconus, Glaucoma (especially cases with chronic inflammation or long-term medication use).
- Developmental fundus diseases in children and adolescents: Coats' Disease, Familial Exudative Vitreoretinopathy (FEVR), Retinopathy of Prematurity (ROP).
Key exclusion criteria (3 listed)
- Recent (within the past 3 months) corneal/conjunctival acute inflammation, ocular surgery, or ocular trauma; or presence of corneal alterations (e.g., contact lens wear).
- Fundus images that are uninterpretable or severely obscured (e.g., vitreous hemorrhage).
- Use of medications affecting tear secretion (e.g., antihistamines, antidepressants) within the past 30 days.
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
Tear Break-Up Time
Time frame: Baseline and within 30 days post-procedure
The time from the last complete blink to the appearance of the first dry spot on the cornea.
Dry Eye Questionnaire-5
Time frame: Baseline and within 30 days post-procedure
The DEQ-5 comprises five items assessing the frequency of dryness, discomfort, and watery eyes, as well as the late-day intensity of dryness and discomfort. Patients rate each item on a 0-4 or 0-5 scale, and the total score is summed. Higher scores indicate greater dry eye symptom severity.
Meibomian Gland Dropout
Time frame: Baseline and within 30 days post-procedure
Meibomian gland dropout will be measured using infrared meibography.
Blink Rate
Time frame: Baseline and within 30 days post-procedure
Blink rate will be measured using a video recording system under natural blinking conditions. The number of complete blinks and incomplete blinks per minute will be counted separately.
Lipid Layer Thickness
Time frame: Baseline and within 30 days post-procedure
Lipid layer thickness refers to the thickness of the lipid layer of the tear film, which is the outermost layer of the precorneal tear film.
Tear Meniscus Height
Time frame: Baseline and within 30 days post-procedure
Tear meniscus height refers to the vertical height of the tear volume accumulated along the lower eyelid margin.
5 secondary outcomes
Central Subfield Thickness
Time frame: Baseline and within 30 days post-procedure
Subfoveal Choroidal Thickness
Time frame: Baseline and within 30 days post-procedure
Subretinal Fluid
Time frame: Baseline and within 30 days post-procedure
Intraretinal Fluid
Time frame: Baseline and within 30 days post-procedure
Pigment Epithelial Detachment Height
Time frame: Baseline and within 30 days post-procedure
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 5 Jun 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.
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 Ocular Surface Disease and Inflammatory Disease, run by Dan Chen 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 9 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: looking for participants now, as of the sponsor's last update on 5 Jun 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?
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?
Tear Break-Up Time (time frame: Baseline and within 30 days post-procedure). The study lists 6 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 5 Jun 2026.