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AzTrials

Retinal DiseasesNCT06918028

An Interpretable Fundus Diseases Report Generating System Based On Weakly Labelings

An observational study of Retinal Diseases and Choroidal Disease, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

To establish a multimodal fundus image report generation model to realize an interpretable system for multiple fundus diseases, multimodal image analysis, diagnosis, and treatment decision automatic reporting based on weakly labeled training data. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
With fundus diseases and Without fundus diseases
How many people
9,999 participants
Where
1 siteChina
Study dates
May 2025to Dec 2026
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: The clinically collected fundus examination images and corresponding reports, including various categories of fundus lesions or normal findings, obtained from examinations conducted at the Zhongshan Ophthalmic Center.

Who may be able to join

  • Disease group: All multimodal fundus examination images containing fundus lesions, examined from January 2011 to December 2023, including fundus photography, as well as OCT, OCTA, FFA, ICGA, B-ultrasound and corresponding imaging reports. Images could be either clear or unclear, reports are either complete or incomplete.
  • Normal group: All multimodal fundus examination images without fundus lesions, examined from January 2011 to December 2023, including fundus photography, as well as OCT, OCTA, FFA, ICGA, B-ultrasound and corresponding imaging reports. Images could be either clear or unclear, reports are either complete or incomplete.

Who cannot join

  • Disease group: 1. The image has serious quality problems; 2. The diagnostic report lacks key information.
  • Normal group: 1. The image has serious quality problems; 2. The diagnostic report lacks key information.

Trial locations and contacts

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

Wenjia Cai, Ph.D. contact

+8615017593912

caiwenjia@gzzoc.com

China1 site
  • Zhongshan Ophthalmic Center

    Guangzhou, Guangdong, 510080

    Ling Jin, +862066604125, jinling@gzzoc.com

Other trials in China

About this study

Official title: To Construct an Interpretable Multi-modal Report Generating System For Fundus Diseases Based On Weakly Labelings

To establish a multimodal fundus image report generation model to realize an interpretable system for multiple fundus diseases, multimodal image analysis, diagnosis, and treatment decision automatic reporting based on weakly labeled training data. Construct an interpretable feature fusion network for the clinical and imaging features of fundus lesions, and we hope to extract new imaging markers that can predict the occurrence and progression of various fundus lesions at an early stage, and ultimately verify them in real clinical data, further providing possible directions for exploring the molecular mechanisms of refractory fundus lesions, and may also provide new ideas for the precise prevention and treatment of fundus lesions.

Read the detailed description
  1. AI models for multimodal fundus imaging in the diagnosis of retinal diseases. AI models have demonstrated significant potential in assisting the diagnosis of various retinal diseases based on multimodal fundus imaging. In recent years, AI has rapidly advanced in the field of fundus disease imaging diagnostics. High-accuracy diagnostic models can be developed using large datasets of precisely annotated single-modal images. Fundus photography, which provides clinicians with an initial diagnostic impression, is widely accessible and can be obtained using simple imaging devices or even mobile devices. For instance, Cen et al. trained a deep learning system using 249,620 precisely annotated fundus photographs to diagnose 39 common retinal diseases, achieving diagnostic accuracies exceeding 90% for each condition. However, fundus photography alone offers limited disease information, making it challenging to differentiate between diseases with similar manifestations. In addition, its diagnostic accuracy is heavily based on image quality and clinician expertise, which may lead to missed or misdiagnosed cases. Optical coherence tomography (OCT) provides a three-dimensional analysis of the retinal layers, clearly revealing the severity and location of pathologies such as intraretinal and subretinal fluid. OCT has become a standard diagnostic and differential diagnostic tool for retinal diseases and is essential to guide the precise treatment and follow-up of conditions such as age-related macular degeneration and diabetic macular edema. AI-assisted OCT analysis can further enhance the follow-up and personalized treatment of retinal diseases. For example, Fauw et al. utilized 14,884 OCT images to diagnose more than 10 retinal diseases and map the location of the lesions. The accurate diagnosis of retinal diseases also relies on dynamic and functional evidence. Fundus fluorescein angiography (FFA) and indocyanine green angiography (ICGA) are indispensable for the location, characterization, and evaluation of the vascular function of the lesion. However, due to the complexity of interpreting angiographic images, the application of AI in FFA and ICGA analysis has only recently gained traction. Moreover, most cases require multimodal imaging, including OCT, fundus photography, and angiography, to comprehensively locate and analyze the disease pathology. Additionally, integrating clinical data and patient medical history is crucial for an accurate diagnosis. Therefore, there is an urgent need to develop new AI models capable of integrating multi-modal data to assist clinicians in accurately diagnosing complex retinal diseases.
  2. AI-Assisted Generation of Complex Medical Reports. The complexity and specialized nature of fundus imaging make image interpretation challenging, and the shortage of clinicians capable of generating precise reports further increases the workload of ophthalmologists and hinders early diagnosis and treatment of retinal diseases. AI-assisted report generation has the potential to address these challenges. Compared to simple image recognition and classification, developing AI models that generate textual interpretations from images is more complex, as it requires the machine to mimic a human-like understanding of image content. "Image-to-text" models incorporate various deep learning algorithms, including computer vision and natural language processing. Early models required millions of natural images to achieve satisfactory text generation, which is impractical for medical imaging due to limited datasets and extensive textual information. However, clinical reports generated by clinicians, based on comprehensive clinical data, detailed image analysis, and experience, can serve as high-quality training datasets for such models. Currently, significant research efforts are focused on areas with large datasets and standardized report formats, such as chest X-rays, chest CT scans, and brain MRI. The widely used report generation databases include Open-IU, MIMIC-CXR, and PadChest, with MIMIC-CXR containing more than 270,000 chest radiograph reports. In ophthalmology, due to the complexity of fundus imaging interpretation and the relatively smaller size of the data set, research in this area is limited, particularly for highly specialized imaging modalities such as fundus angiography. Our team has successfully developed a fundus fluorescein angiography report generation dataset (FFA-IR) based on angiography images and the corresponding reports. Our report generation model can produce accurate bilingual reports (Chinese and English) for common and rare retinal diseases, with accuracy comparable to that of human retinal specialists, while significantly reducing report generation time.
  3. Weak Annotation: A Promising Approach for Training New Disease Diagnosis and Classification Models Traditional AI-assisted diagnostic models for medical imaging typically rely on large-scale, precisely annotated, high-quality images, as the accuracy of the training dataset is critical for model performance. When high annotation accuracy cannot be guaranteed, increasing the dataset size is often the only way to improve model performance. However, for complex datasets like fundus angiography images, the large number of diseases and variable manifestations exponentially increase the annotation difficulty. Additionally, clinical reports often contain uncertainties due to incomplete clinical data or varying levels of clinician expertise, leading to inaccuracies in diagnostic reports.

Weak annotation offers a promising solution to reduce annotation costs, improve annotation efficiency, and improve model generalizability. In natural image processing, weak annotation has been widely studied, with large-scale natural image datasets enabling the training of such models. In medical AI research, Guo et al. pioneered the use of weakly annotated datasets derived from brain CT reports, automatically extracting low-quality keyword information to accurately identify and locate four common brain pathologies. This approach demonstrated excellent generalizability across different centers and imaging devices. However, these systems were limited to broad categories of diseases and single-modal images, lacking the ability to diagnose specific diseases or generate detailed reports.

Based on preliminary findings and literature, we propose a hypothesis: Can weakly annotated imaging reports, combined with AI deep learning algorithms such as knowledge graphs and Transformer, be used to build an interpretable, multi-modal, multi-disease fundus report generation system? This project aims to refine existing AI models and develop a system that helps generate imaging diagnoses and reports for multiple retinal diseases. The results will not only reduce the workload of ophthalmologists, but also promote the widespread adoption of advanced fundus imaging techniques, ultimately improving the early diagnosis and treatment of blinding retinal diseases.

Being tested
With fundus diseases, Without fundus diseases
Medical subject headings
Retinal Diseases, Choroid Diseases, Myopia, Degenerative, Diabetic Retinopathy, Macular Degeneration, Choroidal Neovascularization

What participants receive

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

  • With fundus diseasesOther

    With fundus diseases

  • Without fundus diseasesOther

    Without fundus diseases

Study groups in NCT06918028
Study groupRoleWhat they receive
Disease groupWith retinal or choroidal diseases
Receives: Other: With fundus diseases
Normal groupWithout retinal or choroidal diseases
Receives: Other: Without fundus diseases

What is being measured

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

  1. Fundus Fluorescein Angiography (FFA) images with corresponding report

    Fundus Fluorescein Angiography(FFA) images with corresponding report were collected. FFA allows dynamic observation of changes in retinal blood vessels and lesions.

    Measured: Baseline

  2. Indocyanine Green Angiography (ICGA) images with report

    Indocyanine Green Angiography (ICGA) images with corresponding report were collected. ICGA allows dynamic observation of changes in choroidal blood vessels and lesions.

    Measured: Baseline

  3. Fundus photography with corresponding report

    Fundus photography images with corresponding report were collected. Fundus photography provides observation of morphological manifestations of the retina, the retinal blood vessels, the optic nerve, as well as lesions on the retina.

    Measured: Baseline

  4. Optical coherence tomography (OCT) images with corresponding report

    Optical coherence tomography (OCT) images with corresponding report were collected. OCT images provides observation of changes in retinal thickness, morphology and manifestations of lesions in each retinal or choroidal layer, as well as lesions in the macular area and optic nerve

    Measured: Baseline

  5. Optical coherence tomography angiography (OCTA) images with corresponding report

    Optical coherence tomography angiography (OCTA) images with corresponding report were collected. OCTA images provides observation of the density, morphology, and manifestations of retinal blood vessels, as well as the morphology and manifestations of retinal lesions

    Measured: Baseline

Secondary outcomes (5)
  1. Bilingual Evaluation Understudy (BLEU) analysis

    Bilingual Evaluation Understudy (BLEU) measures how closely a machine-generated text matches the reference texts to quantify the similarity between the generated text and reference texts.

    Measured: Through study completion, an average of 1 year

  2. Metric for Evaluation of Translation with Explicit Ordering (METEOR) analysis

    Metric for Evaluation of Translation with Explicit Ordering (METEOR) considers precision, recall, alignment, and includes stemming and synonymy to quantify the similarity between the generated text and reference texts.

    Measured: Through study completion, an average of 1 year

  3. Recall-Oriented Understudy for Gisting Evaluation (ROUGE) analysis

    Recall-Oriented Understudy for Gisting Evaluation (ROUGE) focuses on recall and measures the overlap of n-grams, contiguous sequences of n items (words, characters, or symbols) extracted from a given sample of text, between the generated and reference texts to quantify the similarity between the generated text and reference texts.

    Measured: Through study completion, an average of 1 year

  4. Pearson correlation analysis

    To determine the degree of linear relationship between human evaluations and automated assessments.

    Measured: Through study completion, an average of 1 year

  5. Intersection-Over-Union (IOU) analysis

    Also known as the Jaccard similarity coefficient, between the attention map regions of lesion images and the ground truth annotations to evaluate the accuracy of model interpretations.

    Measured: Through study completion, an average of 1 year

Timeline

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

  1. First posted9 Apr 2025
  2. Study startMay 2025 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 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
Cohort
Time perspective
Retrospective
Enrolment
9,999 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06918028
Sponsor's protocol ID
2024KYPJ005
Status last verified
Oct 2024
First submitted
3 Mar 2025
Last updated
9 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Retinal Diseases and Choroidal Disease, run by Zhongshan Ophthalmic Center, Sun Yat-sen 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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 9 Apr 2025. 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 Wenjia Cai, Ph.D. (+8615017593912, caiwenjia@gzzoc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fundus Fluorescein Angiography (FFA) images with corresponding report (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 9 Apr 2025.

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