Establishment of a Multimodal Standard Database for Inflammation-related Ophthalmopathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3+
SponsorDan Chen
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial population
The study population includes patients with both inflammatory and non-inflammatory ocular diseases.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
3,000 Participants
are grouped into 2 trial groupsGroup A: Inflammatory-Related Ocular Disease Group
Group B: Non-Inflammatory-Related Ocular Disease Group
Trial outcomes
Primary outcomes
1
Tear Break-Up Time
The time from the last complete blink to the appearance of the first dry spot on the cornea.
Time frame
Baseline and within 30 days post-procedure2
Dry Eye Questionnaire-5
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.
Time frame
Baseline and within 30 days post-procedure3
Meibomian Gland Dropout
Meibomian gland dropout will be measured using infrared meibography.
Time frame
Baseline and within 30 days post-procedure4
Blink Rate
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.
Time frame
Baseline and within 30 days post-procedureSecondary outcomes
1
Central Subfield Thickness
Central subfield thickness refers to the thickness of the retina at the fovea.
Time frame
Baseline and within 30 days post-procedure2
Subfoveal Choroidal Thickness
Subfoveal choroidal thickness refers to the thickness of the choroid directly beneath the fovea.
Time frame
Baseline and within 30 days post-procedure3
Subretinal Fluid
Subretinal fluid refers to fluid accumulation in the potential space between the neurosensory retina and the retinal pigment epithelium.
Time frame
Baseline and within 30 days post-procedure4
Intraretinal Fluid
Intraretinal fluid refers to fluid accumulation within the retinal layers, typically appearing as cystoid spaces.
Time frame
Baseline and within 30 days post-procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Dan Chen
Lead sponsor
Capital Medical University
Sponsor institution
Source ClinicalTrials.gov