An Interpretable Fundus Diseases Report Generating System Based On Weakly Labelings

NCT06918028 | Not Yet Recruiting DMC

• 1 other identifier: 2024KYPJ005
• Study Type: observational
• Target: 9,999
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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.

  Baseline

• 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.

  Baseline

• 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.

  Baseline

• 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

  Baseline

• 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

  Baseline

Secondary Outcomes (5)

• Bilingual Evaluation Understudy (BLEU) analysis

  Through study completion, an average of 1 year

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

  Through study completion, an average of 1 year

• Recall-Oriented Understudy for Gisting Evaluation (ROUGE) analysis

  Through study completion, an average of 1 year

• Pearson correlation analysis

  Through study completion, an average of 1 year

• Intersection-Over-Union (IOU) analysis

  Through study completion, an average of 1 year

Study Arms (2)

Disease group

With retinal or choroidal diseases

Other: With fundus diseases

Normal group

Without retinal or choroidal diseases

Other: Without fundus diseases

Interventions

With fundus diseases OTHER

With fundus diseases

Disease group

Without fundus diseases OTHER

Without fundus diseases

Normal group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Retinal Diseases; Choroid Diseases; Myopia, Degenerative; Diabetic Retinopathy; Macular Degeneration; Choroidal Neovascularization

Condition Hierarchy (Ancestors)

Eye Diseases; Uveal Diseases; Myopia; Refractive Errors; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Retinal Degeneration; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wenjia Cai, Ph.D.

CONTACT

+8615017593912; caiwenjia@gzzoc.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: April 9, 2025
• Study Start: May 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 9, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)