Macular Degeneration, Age RelatedNCT05593913
Clinical Evaluation of VeriSee AMD in Screening for Age-Related Macular Degeneration
An observational study of Macular Degeneration, Age Related and Maculopathy, Age Related, run by Acer Medical Inc. at 1 site in Taiwan.
Trial summary
An observational study is designed to evaluate the clinical performance of VeriSee AMD for potential age-related macular degeneration (AMD) screening from color fundus photography images. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration, Age Related, Maculopathy, Age Related
- How many people
- 986 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Jan 2022to 10 Aug 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People fifty years of age or older have color fundus photography images.
Who may be able to join
- Subject with age ≥ 50 years old
- Subject with image taken by color fundus photography that meet the following requirement:
- The resolution of image is 271x271 pixels or higher;
- The angle view of image is 45 or 50 degree.
- Subject's image includes macula as judged by the ophthalmologist.
Who cannot join
- The color fundus photography image previously used by VeriSee AMD during the development process and pre-clinical test
- The macula or other part in the image of color fundus photography is unclear to determine the disease condition as judged by the ophthalmologist.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Retrospective Study to Evaluate the Clinical Performance of Artificial Intelligence Medical Assisted Diagnostic Software (VeriSee AMD) for Screening of Age-Related Macular Degeneration
An observational study is designed to evaluate the clinical performance of VeriSee AMD for potential age-related macular degeneration (AMD) screening from color fundus photography images. The sensitivity and specificity of VeriSee AMD's automated image analysis for screening AMD will be determined through the comparison with the gold standard, which is the judgment of AMD by the ophthalmologists.
Read the detailed description
This is a retrospective, single-center, observational study to assess the clinical performance of VeriSee AMD in screening for potential age-related macular degeneration (AMD).
Potential subjects with images of color fundus photography will be selected for eligibility, and then the ophthalmologist further confirms the images with legible quality. Three independent ophthalmologists (or evaluators) having more than 6 years of experience in retina will evaluate AMD from the color fundus photography images with different sequences of images independently. These three evaluators are different from the ophthalmologist who is responsible for deciding subject's eligibility. The evaluators determine the severity of AMD based on the four-level scale which is the AMD Severity Scale stated in Age-Related Eye Disease Study (AREDS) Report No. 6. Before the study, the training section is necessary to ensure the consensus of the AMD severity grading among three evaluators. The severity determined by the majority of the grade the three evaluators gave is considered the gold/reference standard in this study. Therefore, level 1 and level 2 are classified as non-mtl3AMD, while level 3 and advanced AMD (level 4) are classified as mtl3AMD. The clinical performance displayed as sensitivity and specificity will be determined by comparing the AMD results between VeriSee AMD and the gold standard.
VeriSee AMD is intended to screen AMD from the images taken by color fundus photography, which can assist the physicians to assess whether further examination for retinopathy by the ophthalmologist is needed. The screening result of AMD will be non-mtl3AMD or mtl3AMD for the physicians' reference and does not intend to diagnose AMD, detect concomitant diseases, or treat AMD.
- Medical subject headings
- Macular Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
To evaluate the clinical performance of VeriSee AMD by determining the sensitivity.
Sensitivity = 100% x TP/(TP+FN)
Measured: 1 day
Specificity
To evaluate the clinical performance of VeriSee AMD by determining the Specificity.
Specificity = 100% x TN/(TN+FP)
Measured: 1 day
Secondary outcomes (3)
Positive Predictive Values (PPV)
To evaluate the clinical performance of VeriSee AMD by determining the positive predictive values (PPV).
Positive predictive value (PPV) =100% x TP/(TP+FP)
Measured: 1 day
Negative Predictive Values (NPV)
To evaluate the clinical performance of VeriSee AMD by determining the negative predictive values (NPV).
Negative predictive value (NPV) = 100% x TN/(FN+TN)
Measured: 1 day
The Percentage of Subjects' Images With Insufficient Quality as Judged by VeriSee AMD
The percentage of the images with insufficient quality as determined by VeriSee AMD will be presented.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start17 Jan 2022
- Primary completion3 Mar 2022
- Study completion10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Macular Degeneration, Age RelatedStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 986 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acer Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Taiwan University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593913
- Sponsor's protocol ID
- AHCI21001
- Status last verified
- Apr 2023
- First submitted
- 18 Oct 2022
- Last updated
- 22 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Retrospective Study to Evaluate the Clinical Performance of Artificial Intelligence Medical Assisted Diagnostic Software (VeriSee AMD) for Screening of Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT05593913
- Acronym / sponsor ID
- AHCI21001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 986 participants (actual)
- Lead sponsor
- Acer Medical Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Taiwan University Hospital
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 3 Mar 2022 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 26 Oct 2022 (actual)
- Results
- Posted 22 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An observational study is designed to evaluate the clinical performance of VeriSee AMD for potential age-related macular degeneration (AMD) screening from color fundus photography images. The sensitivity and specificity of VeriSee AMD's automated image analysis for screening AMD will be determined through the comparison with the gold standard, which is the judgment of AMD by the ophthalmologists.
Detailed description
This is a retrospective, single-center, observational study to assess the clinical performance of VeriSee AMD in screening for potential age-related macular degeneration (AMD).
Potential subjects with images of color fundus photography will be selected for eligibility, and then the ophthalmologist further confirms the images with legible quality. Three independent ophthalmologists (or evaluators) having more than 6 years of experience in retina will evaluate AMD from the color fundus photography images with different sequences of images independently. These three evaluators are different from the ophthalmologist who is responsible for deciding subject's eligibility. The evaluators determine the severity of AMD based on the four-level scale which is the AMD Severity Scale stated in Age-Related Eye Disease Study (AREDS) Report No. 6. Before the study, the training section is necessary to ensure the consensus of the AMD severity grading among three evaluators. The severity determined by the majority of the grade the three evaluators gave is considered the gold/reference standard in this study. Therefore, level 1 and level 2 are classified as non-mtl3AMD, while level 3 and advanced AMD (level 4) are classified as mtl3AMD. The clinical performance displayed as sensitivity and specificity will be determined by comparing the AMD results between VeriSee AMD and the gold standard.
VeriSee AMD is intended to screen AMD from the images taken by color fundus photography, which can assist the physicians to assess whether further examination for retinopathy by the ophthalmologist is needed. The screening result of AMD will be non-mtl3AMD or mtl3AMD for the physicians' reference and does not intend to diagnose AMD, detect concomitant diseases, or treat AMD.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People fifty years of age or older have color fundus photography images.
Key inclusion criteria (5 listed)
- Subject with age ≥ 50 years old
- Subject with image taken by color fundus photography that meet the following requirement:
- Subject's image includes macula as judged by the ophthalmologist.
Key exclusion criteria (2 listed)
- The color fundus photography image previously used by VeriSee AMD during the development process and pre-clinical test
- The macula or other part in the image of color fundus photography is unclear to determine the disease condition as judged by the ophthalmologist.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity
Time frame: 1 day
To evaluate the clinical performance of VeriSee AMD by determining the sensitivity. Sensitivity = 100% x TP/(TP+FN)
Specificity
Time frame: 1 day
To evaluate the clinical performance of VeriSee AMD by determining the Specificity. Specificity = 100% x TN/(TN+FP)
3 secondary outcomes
Positive Predictive Values (PPV)
Time frame: 1 day
Negative Predictive Values (NPV)
Time frame: 1 day
The Percentage of Subjects' Images With Insufficient Quality as Judged by VeriSee AMD
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Macular Degeneration, Age Related and Maculopathy, Age Related, run by Acer Medical Inc. at 1 site in Taiwan.
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 5 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 22 Jan 2024. 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 Taiwan. 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?
Yes. Results are posted in the registry (first posted 22 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sensitivity (time frame: 1 day). The study lists 2 primary outcomes in all. 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 22 Jan 2024.