Cytomegalovirus RetinitisNCT04831333
Deep Learning-based System and AIDS-related Cytomegalovirus Retinitis
An observational study of Cytomegalovirus Retinitis, run by Kuifang Du at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus Retinitis
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 1 May 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: AIDS patients undergoing OPTOS camera (OPTOS® Daytona) from Department of Ophthalmology, Beijing Youan Hospital, were prospectively collected as a prospective dataset.
Who may be able to join
- The UWF images from HIV/AIDS patients.
Who cannot join
- The UWF images would be excluded if all three human graders gave different diagnosis.
- The UWF images with poor quality would be excluded.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Youan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100069
About this study
Official title: 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.
- Conditions
- Cytomegalovirus Retinitis
- Keywords
- AIDS, HIV, Cytomegalovirus Retinitis, Deep learning, Ultra-wide-field imaging
- Medical subject headings
- Cytomegalovirus Retinitis, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: April 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start1 Apr 2021
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus RetinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kuifang Du
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tongren Hospital
- Responsible party
- Sponsor-investigator, Kuifang Du, Beijing YouAn Hospital
- Investigators
- Kui-Fang Du, Study director, Beijing YouAn HospitalLi Dong, Study director, Beijing Tongren HospitalKai Zhang, Principal investigator, Beijing Tongren HospitalChao Chen, Principal investigator, Beijing YouAn HospitalLian-Yong Xie, Principal investigator, Beijing YouAn HospitalWen-Jun Kong, Principal investigator, Beijing YouAn HospitalHong-Wei Dong, Principal investigator, Beijing YouAn HospitalHe-Yan Li, Principal investigator, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04831333
- Sponsor's protocol ID
- 20210331001
- Status last verified
- Jul 2021
- First submitted
- 1 Apr 2021
- Last updated
- 21 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Learning-based System for Detection of AIDS-related Cytomegalovirus Retinitis in Ultra-Widefield Fundus Images
- ClinicalTrials.gov ID
- NCT04831333
- Acronym / sponsor ID
- 20210331001
- Conditions
- Cytomegalovirus Retinitis
- Keywords
- AIDS, HIV, Cytomegalovirus Retinitis, Deep learning, Ultra-wide-field imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kuifang DuUniversity, hospital or other
- Collaborators
- Beijing Tongren Hospital
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- AIDS patients undergoing OPTOS camera (OPTOS® Daytona) from Department of Ophthalmology, Beijing Youan Hospital, were prospectively collected as a prospective dataset.
Key inclusion criteria (1 listed)
- The UWF images from HIV/AIDS patients.
Key exclusion criteria (2 listed)
- The UWF images would be excluded if all three human graders gave different diagnosis.
- The UWF images with poor quality would be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other | Active CMVR, Inactive CMVR, Non-CMVR |
Primary outcome
Evaluating the applicability of the DL system to identify AIDS-related CMVR
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kui-Fang Du study director
Beijing YouAn Hospital
Li Dong study director
Beijing Tongren Hospital
Kai Zhang principal investigator
Beijing Tongren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytomegalovirus Retinitis, run by Kuifang Du at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating the applicability of the DL system to identify AIDS-related CMVR (time frame: April 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.