Zhongshan Ophthalmic Center
Guangzhou, Guangdong, 510080, China
NCT Number: NCT06918028
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.
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Observational
Guangzhou, Guangdong, 510080, China
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.
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.
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
With fundus diseases
Without fundus diseases
Time frame: Baseline
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
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
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
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
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: Through study completion, an average of 1 year
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
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
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
To determine the degree of linear relationship between human evaluations and automated assessments.
Time frame: Through study completion, an average of 1 year
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.
Contact information is provided by the study sponsor or research team.
Zhongshan Ophthalmic Center, Sun Yat-sen University
Other
To Construct an Interpretable Multi-modal Report Generating System For Fundus Diseases Based On Weakly Labelings
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