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Establishment of a Multimodal Standard Database for Inflammation-related Ophthalmopathy

2026年6月1日 更新者：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.

研究概览

地位

招聘中

条件

研究类型

观察性的

注册 (估计的)

3000

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
      • Beijing、中国
        • 招聘中
        • Beijing Tongren Hospital
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

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

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
Inflammatory-Related Ocular Disease Group
Non-Inflammatory-Related Ocular Disease Group

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Tear Break-Up Time
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Central Subfield Thickness
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Dan Chen

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年11月26日

初级完成 (估计的)

2030年2月1日

研究完成 (估计的)

2030年2月1日

研究注册日期

首次提交

2026年5月26日

首先提交符合 QC 标准的

2026年6月1日

首次发布 (实际的)

2026年6月5日

研究记录更新

最后更新发布 (实际的)

2026年6月5日

上次提交的符合 QC 标准的更新

2026年6月1日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • TREC2026-KY044

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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