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NCT Number: NCT07628946

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.

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Key information

Conditions

Ocular Surface Disease Choroid Diseases Eye Diseases Inflammatory Disease Retinal Disease Retinal Diseases Uveal Diseases

Age range

3 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. Meibomian Gland Dropout

    Time frame: Baseline and within 30 days post-procedure

    Meibomian gland dropout will be measured using infrared meibography.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. Central Subfield Thickness

    Time frame: Baseline and within 30 days post-procedure

    Central subfield thickness refers to the thickness of the retina at the fovea.

  2. Subfoveal Choroidal Thickness

    Time frame: Baseline and within 30 days post-procedure

    Subfoveal choroidal thickness refers to the thickness of the choroid directly beneath the fovea.

  3. Subretinal Fluid

    Time frame: Baseline and within 30 days post-procedure

    Subretinal fluid refers to fluid accumulation in the potential space between the neurosensory retina and the retinal pigment epithelium.

  4. Intraretinal Fluid

    Time frame: Baseline and within 30 days post-procedure

    Intraretinal fluid refers to fluid accumulation within the retinal layers, typically appearing as cystoid spaces.

  5. Pigment Epithelial Detachment Height

    Time frame: Baseline and within 30 days post-procedure

    Pigment epithelial detachment height refers to the maximal vertical height of separation of the retinal pigment epithelium from the underlying Bruch's membrane.

Sponsors and collaborators

Lead sponsor

Dan Chen

Other

Registry information

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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