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Clinical Trials in China / NCT07628946
Recruiting Observational

Establishment of a Multimodal Standard Database for Inflammation-related Ophthalmopathy

NCT07628946 · tracked via the Priya Life Science China tracker
Sponsor
Dan Chen
Phase
Observational
Started
2025-11-26
Last updated
2026-06-05

Condition(s) studied

Ocular Surface DiseaseInflammatory DiseaseRetinal DiseaseChoroid Diseases

Study 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.

Eligibility

Sex
ALL
Min age
3 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Tear Break-Up Time — 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 — 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 — Baseline and within 30 days post-procedure
    Meibomian gland dropout will be measured using infrared meibography.
  • Blink Rate — 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 — 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 — 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.

Trial sites (1)

FacilityCityRegionStatus
Beijing Tongren Hospital Beijing China Recruiting

Other trials for the same condition

Safety and Efficacy Study of IVB102 Injection in Subjects With X-linked Retinoschisis Active, not recruiting
The Efficacy of Intradermal Acupuncture for Ocular Surface Diseases After Intractable Facial Paralysis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07628946 on ClinicalTrials.gov ↗ ← All trials in China