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Establishment of a Multimodal Standard Database for Inflammation-related Ophthalmopathy

1. juni 2026 opdateret af: Dan Chen
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.

Studieoversigt

Status

Rekruttering

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

3000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
      • Beijing, Kina
        • Rekruttering
        • Beijing Tongren Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Inflammatory-Related Ocular Disease Group
Non-Inflammatory-Related Ocular Disease Group

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Tear Break-Up Time
Tidsramme: 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.
Baseline and within 30 days post-procedure
Dry Eye Questionnaire-5
Tidsramme: 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.
Baseline and within 30 days post-procedure
Meibomian Gland Dropout
Tidsramme: Baseline and within 30 days post-procedure
Meibomian gland dropout will be measured using infrared meibography.
Baseline and within 30 days post-procedure
Blink Rate
Tidsramme: 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.
Baseline and within 30 days post-procedure
Lipid Layer Thickness
Tidsramme: 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.
Baseline and within 30 days post-procedure
Tear Meniscus Height
Tidsramme: 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.
Baseline and within 30 days post-procedure

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Central Subfield Thickness
Tidsramme: Baseline and within 30 days post-procedure
Central subfield thickness refers to the thickness of the retina at the fovea.
Baseline and within 30 days post-procedure
Subfoveal Choroidal Thickness
Tidsramme: Baseline and within 30 days post-procedure
Subfoveal choroidal thickness refers to the thickness of the choroid directly beneath the fovea.
Baseline and within 30 days post-procedure
Subretinal Fluid
Tidsramme: 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.
Baseline and within 30 days post-procedure
Intraretinal Fluid
Tidsramme: Baseline and within 30 days post-procedure
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
Tidsramme: 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.
Baseline and within 30 days post-procedure

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Dan Chen

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

26. november 2025

Primær færdiggørelse (Anslået)

1. februar 2030

Studieafslutning (Anslået)

1. februar 2030

Datoer for studieregistrering

Først indsendt

26. maj 2026

Først indsendt, der opfyldte QC-kriterier

1. juni 2026

Først opslået (Faktiske)

5. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TREC2026-KY044

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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