An Assistant Model for IRD Care Needs: A Randomized Control Trial

Last updated: February 20, 2025
Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Retina

Treatment

EyeFM-IRDs assisted

without EyeFM-IRDs

Clinical Study ID

NCT06839170
EyeFM-IRDs
2022YFC2502800
  • All Genders

Study Summary

Conduct a multicenter randomized controlled study based on the comprehensive deep learning model for inherited retinal diseases (EyeFM-IRDs). Through our established comprehensive deep learning model for inherited retinal diseases (EyeFM-IRDs model), the following objectives can be achieved: complete the initial screening of IRD patients based on the EyeFM-IRDs model, improve the correct referral of IRD patients to the fundus specialty or genetic eye disease specialty clinic; through consultation and ophthalmic examination, achieve the goal that the EyeFM-IRDs assisted by fundus doctors can improve the diagnosis of IRD compared to fundus doctors alone, effectively screen out negative patients, and avoid unnecessary WES examinations; based on a panel of gene mutation types with treatment methods that we have previously constructed. The EyeFM-IRDs model predicts the specific mutation genes of IRD patients based on consultation and fundus examination. This will improve the standardized diagnosis and treatment of IRD diseases, and also provide clinical support and research guidance for future research on IRDs.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Presenting with clinical features suggestive of IRD based on the initial assessmentby the physician

Exclusion

Exclusion Criteria:

  • Refusal to undergo WES genetic testing.

  • Screening for a history of intraocular surgery in both eyes within the past 6months;

  • Subjects with severe systemic diseases, intellectual developmental disorders,psychiatric illnesses, etc.

  • Patient data that the investigator deems necessary to exclude.

Study Design

Total Participants: 240
Treatment Group(s): 2
Primary Treatment: EyeFM-IRDs assisted
Phase:
Study Start date:
November 07, 2024
Estimated Completion Date:
May 01, 2025

Connect with a study center

  • Shanghai general hospital

    ShangHai,
    China

    Active - Recruiting

  • Shanghai General Hospital, Shanghai Jiao Tong University

    Shanghai, 200080
    China

    Active - Recruiting

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