Observation of Iris Blood Flow Via OCTA in Diabetic Neovascular Glaucoma

NCT07722910 | Recruiting DMC

• 1 other identifier: KYLL-2026-06-036
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Neovascular Glaucoma; Type 2 Diabetes

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Iris vessel density

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

  Enrollment

Study Arms (4)

Control

Patients without type 2 diabetes

NDR

Patients with type 2 diabetes but without diabetic retinopathy

DR

Patients with type 2 diabetic retinopathy

DR+NVG

Patients with type 2 diabetic retinopathy and neovascular glaucoma

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male and female self-identified genders are all eligible for enrollment, with no gender restrictions for participants aged 18 years or older.
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Related Publications (6)

• Elkholy RE, El Sharkawy AM, Hantash HI, Elaskary EM, Shafik HM, Nawar AE, Almokadem HA. Evaluation of Retinal Microvascular Changes in Juvenile Systemic Lupus Erythematosus Patients Using Optical Coherence Tomography Angiography. Ocul Immunol Inflamm. 2026 Jul 11:1-8. doi: 10.1080/09273948.2026.2690413. Online ahead of print.

  PMID: 42435066 BACKGROUND

• Zhang G, Chen W, Chen H, Lin J, Cen LP, Xie P, Zheng Y, Ng TK, Brelen ME, Zhang M, Pang CP. Risk factors for diabetic retinopathy, diabetic macular edema, and sight-threatening diabetic retinopathy. Asia Pac J Ophthalmol (Phila). 2024 May-Jun;13(3):100067. doi: 10.1016/j.apjo.2024.100067. Epub 2024 May 13.

  PMID: 38750958 BACKGROUND

• Qi Z, Si Y, Feng F, Zhu J, Yang X, Wang W, Zhang Y, Cui Y. Analysis of retinal and choroidal characteristics in patients with early diabetic retinopathy using WSS-OCTA. Front Endocrinol (Lausanne). 2023 May 24;14:1184717. doi: 10.3389/fendo.2023.1184717. eCollection 2023.

  PMID: 37293481 BACKGROUND

• Lidder AK, Paranjpe V, Lauter AJ. Management of Neovascular Glaucoma. Int Ophthalmol Clin. 2023 Oct 1;63(4):167-183. doi: 10.1097/IIO.0000000000000480. Epub 2023 Sep 27. No abstract available.

  PMID: 37755450 BACKGROUND

• Kalogeropoulos D, Moussa G, Sung VC, Pappa C, Kalogeropoulos C. Neovascular Glaucoma: An Update. Klin Monbl Augenheilkd. 2023 Mar;240(3):305-315. doi: 10.1055/a-1956-9348. Epub 2022 Nov 27.

  PMID: 36436509 BACKGROUND

• Barth T, Helbig H. [Diabetic retinopathy]. Klin Monbl Augenheilkd. 2021 Oct;238(10):1143-1159. doi: 10.1055/a-1545-9927. Epub 2021 Aug 11. German.

  PMID: 34380155 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Neovascular; Diabetes Mellitus, Type 2; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Retinal Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications

Central Study Contacts

Yuting Zhang, Doctor of Medicine

CONTACT

+86 185-6008-8152; zhangyt_7085@163.com

Hui Guo, Doctor of Medicine

CONTACT

+86 185-6008-7106; guohui@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start: May 23, 2026
• Primary Completion: July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)