Establishment of a Multimodal Standard Database for Inflammation-related Ophthalmopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Ocular Surface Disease, Inflammatory Disease, Retinal Disease, Choroid Diseases. Basic parameters: from 3 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Tear Break-Up Time [Time frame: Baseline and within 30 days post-procedure]
- Dry Eye Questionnaire-5 [Time frame: Baseline and within 30 days post-procedure]
- Meibomian Gland Dropout [Time frame: Baseline and within 30 days post-procedure]
- Blink Rate [Time frame: Baseline and within 30 days post-procedure]
- Lipid Layer Thickness [Time frame: Baseline and within 30 days post-procedure]
- Tear Meniscus Height [Time frame: Baseline and within 30 days post-procedure]
Secondary outcome measures (5)
- 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]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Beijing Tongren Hospital — Beijing
Identifiers
NCT: NCT07628946 · TREC2026-KY044