Deep Learning-based System and AIDS-related Cytomegalovirus Retinitis

Deep Learning-based System for Detection of AIDS-related Cytomegalovirus Retinitis in Ultra-Widefield Fundus Images

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.

Study Overview

• Status: Completed
• Conditions: Cytomegalovirus Retinitis
• Intervention / Treatment: Other

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100069
      • Beijing Youan Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

AIDS patients undergoing OPTOS camera (OPTOS® Daytona) from Department of Ophthalmology, Beijing Youan Hospital, were prospectively collected as a prospective dataset.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluating the applicability of the DL system to identify AIDS-related CMVR	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.	April 2021

Collaborators and Investigators

• Sponsor: Kuifang Du
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: April 1, 2021
• First Submitted That Met QC Criteria: April 1, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: HIV; AIDS; Deep learning; Cytomegalovirus Retinitis; Ultra-wide-field imaging
• Additional Relevant MeSH Terms: Virus Diseases; Infections; Eye Diseases; Retinal Diseases; DNA Virus Infections; Herpesviridae Infections; Eye Infections; Eye Infections, Viral; Cytomegalovirus Infections; Retinitis; Cytomegalovirus Retinitis
• Other Study ID Numbers: 20210331001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No