Deep Learning-based System and AIDS-related Cytomegalovirus Retinitis

NCT ID: NCT04831333

Last Updated: 2021-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-01

Study Completion Date

2021-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cytomegalovirus Retinitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Intervention Type OTHER

Inactive CMVR

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

Intervention Type OTHER

Non-CMVR

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

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beijing Tongren Hospital

OTHER

Sponsor Role collaborator

Kuifang Du

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kuifang Du

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kui-Fang Du

Role: STUDY_DIRECTOR

Beijing YouAn Hospital

Li Dong

Role: STUDY_DIRECTOR

Beijing Tongren Hospital

Kai Zhang

Role: PRINCIPAL_INVESTIGATOR

Beijing Tongren Hospital

Chao Chen

Role: PRINCIPAL_INVESTIGATOR

Beijing YouAn Hospital

Lian-Yong Xie

Role: PRINCIPAL_INVESTIGATOR

Beijing YouAn Hospital

Wen-Jun Kong

Role: PRINCIPAL_INVESTIGATOR

Beijing YouAn Hospital

Hong-Wei Dong

Role: PRINCIPAL_INVESTIGATOR

Beijing YouAn Hospital

He-Yan Li

Role: PRINCIPAL_INVESTIGATOR

Beijing Tongren Hospital

Rui-Heng Zhang

Role: PRINCIPAL_INVESTIGATOR

Beijing Tongren Hospital

Wen-Da Zhou

Role: PRINCIPAL_INVESTIGATOR

Beijing Tongren Hospital

Hao-Tian Wu

Role: PRINCIPAL_INVESTIGATOR

Beijing Tongren Hospital

Wen-Bin Wei

Role: STUDY_CHAIR

Beijing Tongren Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing Youan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20210331001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Adaptive Optics Retinal Imaging
NCT02317328 RECRUITING