Using a deep learning model to improve care for inherited retinal diseases
A Multi-stage Evaluation Foundation Model for Inherited Retinal Diseases Care Needs: A Randomized Control Trial
NA · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · NCT06839170
This study is testing a new deep learning tool to see if it can help doctors better care for patients with inherited retinal diseases by improving screenings and making more accurate diagnoses.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Sex | All |
| Sponsor | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (other) |
| Locations | 2 sites (Shanghai and 1 other locations) |
| Trial ID | NCT06839170 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a comprehensive deep learning model, EyeFM-IRDs, in assisting with the care of patients with inherited retinal diseases (IRDs). The study aims to enhance the initial screening process, improve referrals to specialized clinics, and increase diagnostic accuracy when compared to traditional methods. By predicting specific gene mutations based on clinical assessments, the model seeks to streamline patient management and reduce unnecessary genetic testing. The trial is multicenter and randomized, ensuring a robust evaluation of the model's impact on patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals presenting with clinical features suggestive of inherited retinal diseases.
Not a fit: Patients who have severe systemic diseases, intellectual developmental disorders, or psychiatric illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate diagnoses and better-targeted treatments for patients with inherited retinal diseases.
How similar studies have performed: Other studies utilizing deep learning models for medical diagnostics have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Presenting with clinical features suggestive of IRD based on the initial assessment by the physician Exclusion Criteria: * Refusal to undergo WES genetic testing. * Screening for a history of intraocular surgery in both eyes within the past 6 months; * Subjects with severe systemic diseases, intellectual developmental disorders, psychiatric illnesses, etc. * Patient data that the investigator deems necessary to exclude.
Where this trial is running
Shanghai and 1 other locations
- Shanghai General Hospital, Shanghai Jiao Tong University — Shanghai, China (RECRUITING)
- Shanghai general hospital — ShangHai, China (RECRUITING)
Study contacts
- Principal investigator: Xiaodong Sun, PhD — Shanhai General Hopsital
- Study coordinator: Xiaodong Prof. Sun, PhD
- Email: xdsun@sjtu.edu.cn
- Phone: 86 18017317575
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Inherited Retinal Diseases