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Observation of Iris Blood Flow Via OCTA in Diabetic Neovascular Glaucoma

Analysis of the Identification Value and Quadrant Characteristics of Iris OCTA Blood Flow Quantification in Type 2 Diabetic Neovascular Glaucoma

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07722910
Enrollment
98
Registered
2026-07-23
Start date
2026-05-23
Completion date
2026-12-31
Last updated
2026-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neovascular Glaucoma, Type 2 Diabetes

Keywords

Diabetic retinopathy, Neovascular glaucoma, Optical coherence tomography angiography, Iris vessel density, Anti-VEGF therapy

Brief summary

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.

Interventions

None listed

Sponsors

Qilu Hospital of Shandong University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* 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).

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Iris vessel densityEnrollmentIris vessel density measured by Optical Coherence Tomography Angiography(OCTA)

Countries

China

Contacts

CONTACTYuting Zhang, Doctor of Medicine
zhangyt_7085@163.com+86 185-6008-8152
CONTACTHui Guo, Doctor of Medicine
guohui@sdu.edu.cn+86 185-6008-7106

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 29, 2026