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Not yet recruitingNCT06918028Updated Apr 9, 2025

An Interpretable Fundus Diseases Report Generating System Based On Weakly Labelings

An observational study in Retinal Diseases, Choroidal Disease and Pathological Myopia, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Not yet recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2025-04-09.

Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
9,999
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Retinal Diseases
  • Choroidal Disease
  • Pathological Myopia
  • Diabetic Retinopathy
  • Age Related Macular Degeneration
  • Choroidal Neovascularization
03

In context

Retinal Diseases

333 studies on the registry are indexed under Retinal Diseases; 60 are open to participants now.

This study's planned enrollment of 9,999 is above the median of 200 across 118 observational studies indexed under Retinal Diseases.

Browse Retinal Diseases studies →

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 164 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
9,999 participants (estimated)
Patient registry
No

Groups and cohorts

  • Disease group

    With retinal or choroidal diseases

    Other: With fundus diseases

  • Normal group

    Without retinal or choroidal diseases

    Other: Without fundus diseases

Interventions

  • OtherWith fundus diseases

    With fundus diseases

  • OtherWithout fundus diseases

    Without fundus diseases

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: Baseline

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Through study completion, an average of 1 year

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2025; primary completion for Dec 2025, 7 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 3, 2025
First posted
Apr 9, 2025
StartEst.
May 2025
Primary completionEst.
Dec 2025
CompletionEst.
Dec 2026
Last update
Apr 9, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06918028
Responsible party
Sponsor
First posted
Apr 9, 2025
Start date
May 2025 (estimated)
Primary completion
Dec 2025 (estimated)
Completion
Dec 2026 (estimated)
Last update
Apr 9, 2025

Study contacts

Wenjia Cai, Ph.D.
Contact
caiwenjia@gzzoc.com
+8615017593912

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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