Observation of Iris Blood Flow Via OCTA in Diabetic Neovascular Glaucoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorQilu Hospital of Shandong University
About this trial
The goal of this observational study is to quantify iris blood flow via non-invasive eye scanning for evaluating ocular lesions in adults aged 18 years and older, including healthy volunteers, patients with type 2 diabetes mellitus (T2DM) without fundus lesions, T2DM patients with diabetic retinopathy (DR), and T2DM patients complicated with both DR and neovascular glaucoma (NVG). The main questions it aims to answer are:
* Does iris blood flow fraction at six pupillary quadrants differ significantly among people with different stages of type 2 diabetic eye complications? * Are there quadrant-specific and gender-based differences in iris microcirculation changes caused by diabetic eye diseases? If there is a comparison group: Researchers will compare iris blood flow data from four groups (healthy controls, T2DM without DR, T2DM with DR, T2DM with DR + NVG) to see how iris blood circulation changes as diabetic eye conditions get worse, and test whether iris blood flow indicators can help identify patients with neovascular glaucoma.
Participants will complete the following tasks:
* Provide basic personal information, past medical history and recent laboratory test results from their routine medical records; * Receive a painless, non-invasive iris OCTA eye scan to capture iris blood flow images at six quadrants around the pupil.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥ 18 years of age, regardless of gender, with or without type 2 diabetes mellitus and its associated ocular complications; clear consciousness, capable of cooperating with iris OCTA examination (able to stabilize the head to guarantee successful acquisition and interpretable images).
Voluntary participation in this study with signed written informed consent.
No history of intraocular surgery in the examined eye (including cataract surgery, glaucoma filtering surgery, retinal surgery, etc.).
General physical conditions: No acute disease episodes within the recent 3 months (such as acute myocardial infarction, stroke, diabetic ketoacidosis); no severe liver or renal dysfunction (ALT and AST ≤ 2 times the upper limit of normal, serum creatinine ≤ 133 μmol/L).
Disqualifiers
The studied eye suffers from other ocular diseases that may interfere with examination results apart from the disorders specified in Criterion 1 of the inclusion criteria (e.g., uveitis, retinal vein occlusion, high myopia-related fundus lesions, etc.); invasive ocular treatments were administered to the studied eye within the past 6 months (e.g., retinal laser photocoagulation, intravitreal injection, etc.).
Subjects complicated with type 1 diabetes mellitus, gestational diabetes mellitus or other specific types of diabetes mellitus; those with autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus) or hematological diseases (e.g., leukemia, aplastic anemia); individuals who have taken medications affecting ocular microcirculation (e.g., alprostadil, nitrates) within the past 3 months and are unable to discontinue such drugs.
Subjects with severe head tremors and inability to maintain a fixed posture during examination, resulting in substandard OCTA image quality (interpretable area < 80%); those with mental disorders or cognitive dysfunction who fail to understand and cooperate with the examination procedures.
Trial population
The study population consists of adults aged 18 years or older of all genders who visit Qilu Hospital, Shandong University. Participants are divided into four groups: healthy volunteers without type 2 diabetes mellitus, patients with type 2 diabetes without fundus lesions, patients with type 2 diabetes combined with diabetic retinopathy, and patients with type 2 diabetic retinopathy complicated by neovascular glaucoma. All subjects have clear consciousness and can cooperate to complete iris OCTA examination, with no contraindications specified in the exclusion criteria.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
98 Participants
are grouped into 4 trial groupsGroup A: Control
Group B: NDR
Group C: DR
Group D: DR+NVG
Trial outcomes
Primary outcomes
1
Iris vessel density
Iris vessel density measured by Optical Coherence Tomography Angiography(OCTA)
Time frame
EnrollmentSponsors and contacts
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Source ClinicalTrials.gov