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Neovascular GlaucomaNCT07722910

Observation of Iris Blood Flow Via OCTA in Diabetic Neovascular Glaucoma

An observational study of Neovascular Glaucoma and Type 2 Diabetes, run by Qilu Hospital of Shandong University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neovascular Glaucoma, Type 2 Diabetes
How many people
98 participants
Where
1 siteChina
Study dates
23 May 2026to 31 Dec 2026
How long will I take part?
2 Weeks
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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).

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

China1 site, 1 recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

    Yuting Zhang, Doctor of Medicine, +86 185-6008-8152, zhangyt_7085@163.com

    Recruiting

Other trials in China

About this study

Official title: Analysis of the Identification Value and Quadrant Characteristics of Iris OCTA Blood Flow Quantification in Type 2 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.
Read more

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.
Keywords
Diabetic retinopathy, Neovascular glaucoma, Optical coherence tomography angiography, Iris vessel density, Anti-VEGF therapy
Medical subject headings
Glaucoma, Neovascular, Diabetes Mellitus, Type 2, Diabetic Retinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07722910
Study groupRoleWhat they receive
ControlPatients without type 2 diabetes
NDRPatients with type 2 diabetes but without diabetic retinopathy
DRPatients with type 2 diabetic retinopathy
DR+NVGPatients with type 2 diabetic retinopathy and neovascular glaucoma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Iris vessel density

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

    Measured: Enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2026
  2. Study start23 May 2026
  3. Primary completion31 Jul 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
98 participants (estimated)
Target duration
2 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT07722910
Sponsor's protocol ID
KYLL-2026-06-036
Status last verified
Jul 2026
First submitted
20 Jul 2026
Last updated
28 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This study contains sensitive personal medical records and iris imaging data of participants, which involves patient privacy protection. There is no plan to upload individual participant data to public databases or share raw IPD with external researchers. All individual-level identifiable data will not be shared externally to comply with hospital ethics and privacy regulations.

Publications

  • 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 Aug;34(6):1318-1325. doi: 10.1080/09273948.2026.2690413. Epub 2026 Jul 11.

    PubMed 42435066

  • 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.

    PubMed 38750958

  • 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.

    PubMed 37293481

  • 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.

    PubMed 37755450

  • 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.

    PubMed 36436509

  • 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.

    PubMed 34380155

Questions about this trial

What is this clinical trial studying?

An observational study of Neovascular Glaucoma and Type 2 Diabetes, run by Qilu Hospital of Shandong University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yuting Zhang, Doctor of Medicine (+86 185-6008-8152, zhangyt_7085@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Iris vessel density (time frame: Enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07722910, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.

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