Deep Learning-based System and AIDS-related Cytomegalovirus Retinitis

Cytomegalovirus Retinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04831333
• Other study ID #: 20210331001
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: May 1, 2021

Study information

• Verified date: July 2021
• Source: Beijing YouAn Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cytomegalovirus Retinitis
• Retinitis

Locations

Country	Name	City	State
China	Beijing Youan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Kuifang Du	Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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