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Deep Learning-based System and AIDS-related Cytomegalovirus Retinitis

Sponsor
Kuifang Du (Other)
Overall Status
Completed
CT.gov ID
NCT04831333
Collaborator
Beijing Tongren Hospital (Other)
50
Enrollment
1
Location
30
Actual Duration (Days)
50.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Ophthalmological screening for cytomegalovirus retinitis (CMVR) for HIV/AIDS patients is important. However, the manual screening with fundus imaging is laborious and subjective.

Deep learning (DL) system has been developed for the automated detection of various eye diseases with high accuracy and efficiency, including diabetic retinopathy, glaucoma, age-related macular degeneration (AMD), papilledema, lattice degeneration and retinal breaks, from ocular fundus photographs. UWF imaging is a relatively new imaging modality for DL system but has also shown extraordinary talents in automatic retinal analysis With the press for routine CMVR screening in AIDS patients and the great capacity of DL system, the use of deep learning (DL) system to AIDS-related CMVR with Ultra-Widefield (UWF) fundus images is promising.

The investigators previously developed a DL system to detect AIDS-related CMVR. For further evaluating the applicability of the DL system, a prospective dataset is needed.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    50 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Deep Learning-based System for Detection of AIDS-related Cytomegalovirus Retinitis in Ultra-Widefield Fundus Images
    Actual Study Start Date :
    Apr 1, 2021
    Actual Primary Completion Date :
    May 1, 2021
    Actual Study Completion Date :
    May 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Active CMVR

    The UWF images of cytomegalovirus retinitis (CMVR) included various patterns: hemorrhagic necrotizing lesion, granular lesion, frosted branch angiitis, and optic neuropathy lesion. Active CMVR lesion was defined as obvious opacity (mild, moderate, severe, very severe)
    Inactive CMVR

    Inactive CMVR lesion was defined as a lack of opacity or questionable/equivocal activity.
    Non-CMVR

    The non-CMVR images included normal retina and other retinopathies such as HIV-related microvascular retinopathy, diabetic retinopathy, retinal detachment, vitreous hemorrhage.

    Outcome Measures

    Primary Outcome Measures

    1. Evaluating the applicability of the DL system to identify AIDS-related CMVR [April 2021]

      The investigators compared the performance between two trained (senior and junior) retinal ophthalmologists with the DL system. A senior retinal ophthalmologist and a junior retinal ophthalmologist were asked to independently screen the UWF images in the prospective dataset. Accuracy, sensitivity and specificity were used to evaluate the performance.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    The UWF images from HIV/AIDS patients.

    Exclusion Criteria:

    1. The UWF images would be excluded if all three human graders gave different diagnosis.

    2. The UWF images with poor quality would be excluded.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Youan Hospital, Capital Medical University Beijing Beijing China 100069

    Sponsors and Collaborators

    • Kuifang Du
    • Beijing Tongren Hospital

    Investigators

    • Study Director: Kui-Fang Du, Beijing YouAn Hospital
    • Study Director: Li Dong, Beijing Tongren Hospital
    • Principal Investigator: Kai Zhang, Beijing Tongren Hospital
    • Principal Investigator: Chao Chen, Beijing YouAn Hospital
    • Principal Investigator: Lian-Yong Xie, Beijing YouAn Hospital
    • Principal Investigator: Wen-Jun Kong, Beijing YouAn Hospital
    • Principal Investigator: Hong-Wei Dong, Beijing YouAn Hospital
    • Principal Investigator: He-Yan Li, Beijing Tongren Hospital
    • Principal Investigator: Rui-Heng Zhang, Beijing Tongren Hospital
    • Principal Investigator: Wen-Da Zhou, Beijing Tongren Hospital
    • Principal Investigator: Hao-Tian Wu, Beijing Tongren Hospital
    • Study Chair: Wen-Bin Wei, Beijing Tongren Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kuifang Du, Principal investigator, Beijing YouAn Hospital
    ClinicalTrials.gov Identifier:
    NCT04831333
    Other Study ID Numbers:
    • 20210331001
    First Posted:
    Apr 5, 2021
    Last Update Posted:
    Jul 21, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kuifang Du, Principal investigator, Beijing YouAn Hospital
    AIDS
    HIV
    Cytomegalovirus Retinitis
    Deep learning
    Ultra-wide-field imaging
    Additional relevant MeSH terms:
    Cytomegalovirus Retinitis
    Retinitis

    Study Results

    No Results Posted as of Jul 21, 2021