Establishment of a Multimodal Standard Database for Inflammation-related Ophthalmopathy

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 Overview

• Status: Recruiting
• Conditions: Choroid Diseases; Ocular Surface Disease; Retinal Disease; Inflammatory Disease

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Tongren Hospital
    • Contact: Jin Yuan; Phone Number: +86 13825141659; Email: yuanjincornea@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population includes patients with both inflammatory and non-inflammatory ocular diseases.

Description

Inclusion Criteria:

1. Retinal vascular and metabolic-related diseases: Diabetic Retinopathy (DR, including NPDR and PDR), Retinal Vein Occlusion (RVO), Hypertensive Retinopathy.
2. Degenerative diseases: Age-related Macular Degeneration (including dry and wet forms), Pathologic Myopia (PM), Polypoidal Choroidal Vasculopathy (PCV).
3. 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).
4. 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).
5. Developmental fundus diseases in children and adolescents: Coats' Disease, Familial Exudative Vitreoretinopathy (FEVR), Retinopathy of Prematurity (ROP).
6. 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.
7. 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.
8. Availability of complete or follow-up accessible ophthalmic medical records.
9. Blood pressure ≤ 160/100 mmHg (to avoid exacerbating ischemia due to uncontrolled hypertension).

Exclusion Criteria:

1. 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).
2. Fundus images that are uninterpretable or severely obscured (e.g., vitreous hemorrhage).
3. Use of medications affecting tear secretion (e.g., antihistamines, antidepressants) within the past 30 days.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Inflammatory-Related Ocular Disease Group
Non-Inflammatory-Related Ocular Disease Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tear Break-Up Time	The time from the last complete blink to the appearance of the first dry spot on the cornea.	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.	Baseline and within 30 days post-procedure
Meibomian Gland Dropout	Meibomian gland dropout will be measured using infrared meibography.	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.	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.	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.	Baseline and within 30 days post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central Subfield Thickness	Central subfield thickness refers to the thickness of the retina at the fovea.	Baseline and within 30 days post-procedure
Subfoveal Choroidal Thickness	Subfoveal choroidal thickness refers to the thickness of the choroid directly beneath the fovea.	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.	Baseline and within 30 days post-procedure
Intraretinal Fluid	Intraretinal fluid refers to fluid accumulation within the retinal layers, typically appearing as cystoid spaces.	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.	Baseline and within 30 days post-procedure

Collaborators and Investigators

• Sponsor: Dan Chen

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2025
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2030

Study Registration Dates

• First Submitted: May 26, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Retinal Diseases; Choroid Diseases
• Other Study ID Numbers: TREC2026-KY044

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No