Deep Learning-based System and AIDS-related Cytomegalovirus Retinitis

NCT04831333 | Completed

• 1 other identifier: 20210331001
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cytomegalovirus Retinitis

Keywords

AIDS; HIV; Cytomegalovirus Retinitis; Deep learning; Ultra-wide-field imaging

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• The UWF images from HIV/AIDS patients.

You may not qualify if:

• The UWF images would be excluded if all three human graders gave different diagnosis.
• The UWF images with poor quality would be excluded.

Sponsors & Collaborators

• Kuifang Du: lead
• Beijing Tongren Hospital: collaborator

Study Sites (1)

Beijing Youan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100069, China

Location

MeSH Terms

Conditions

Cytomegalovirus Retinitis; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Eye Infections, Viral; Eye Infections; Infections; Cytomegalovirus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Eye Diseases; Retinitis; Retinal Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Kui-Fang Du

  Beijing YouAn Hospital

  STUDY DIRECTOR

• Li Dong

  Beijing Tongren Hospital

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

• Wen-Bin Wei

  Beijing Tongren Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 5, 2021
• Study Start: April 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: July 21, 2021

Record last verified: 2021-07

Locations

CN (1)