Establishment of a Multimodal Standard Database for Inflammation-related Ophthalmopathy

NCT07628946 | Recruiting

• 1 other identifier: TREC2026-KY044
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Ocular Surface Disease; Inflammatory Disease; Retinal Disease; Choroid Diseases

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• Central Subfield Thickness

  Baseline and within 30 days post-procedure

• Subfoveal Choroidal Thickness

  Baseline and within 30 days post-procedure

• Subretinal Fluid

  Baseline and within 30 days post-procedure

• Intraretinal Fluid

  Baseline and within 30 days post-procedure

• Pigment Epithelial Detachment Height

  Baseline and within 30 days post-procedure

Study Arms (2)

Inflammatory-Related Ocular Disease Group

Non-Inflammatory-Related Ocular Disease Group

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dan Chen: lead

Study Sites (1)

Beijing Tongren Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Retinal Diseases; Choroid Diseases

Condition Hierarchy (Ancestors)

Eye Diseases; Uveal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 5, 2026
• Study Start: November 26, 2025
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2030
• Last Updated: June 5, 2026

Record last verified: 2026-06

Locations

CN (1)