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NCT Number: NCT07722910

Observation of Iris Blood Flow Via OCTA in Diabetic Neovascular Glaucoma

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location status: Recruiting

Location contact

Yuting Zhang, Doctor of Medicine

CONTACT

[email protected]

+86 185-6008-8152

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Iris vessel density

    Time frame: Enrollment

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

Study contacts

Contact information is provided by the study sponsor or research team.

Hui Guo, Doctor of Medicine

CONTACT

[email protected]

+86 185-6008-7106

Yuting Zhang, Doctor of Medicine

CONTACT

[email protected]

+86 185-6008-8152

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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