Diabetic RetinopathyCOCONCT05022615
Comparing 3 Imaging Systems
An observational study of Diabetic Retinopathy, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the quality of ocular images captured on 3 different cameras of patients with diabetic retinopathy. The study will determine whether diabetic retinopathy assessment is comparable between the cameras. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Topcon Camera, Optos Camera and Clarus Camera
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2021to 7 Mar 2023
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients (18 or older) with either Type 1 or Type 2 diabetes presenting at a single center of an ophthalmic retina practice for examination of diabetic retinopathy including color photography for standard medical care.
Who may be able to join
- any race
- Established diagnosis of diabetes.
- Willing to participate as evidenced by signing the written informed consent.
Who cannot join
- Unable to tolerate ophthalmic imaging.
- Ocular is media not sufficiently clear to obtain technically acceptable ultrawide field images.
- History of panretinal laser photocoagulation or vitrectomy (history of anti-vascular endothelial growth factor treatment is not an exclusion criteria).
- Presences of confounding abnormalities such as age-related macular degeneration, retinal vein occlusion.
Trial locations and contacts
1 site in 1 country.
United States1 site
UW Health - University Station Clinic
Madison, Wisconsin, 53705
About this study
Official title: Comparison of Standard and Ultrawide Field Imaging Systems
The purpose of this study is to evaluate the quality of ocular images captured on 3 different cameras of patients with diabetic retinopathy. The study will determine whether diabetic retinopathy assessment is comparable between the cameras. The research is being done to see if a camera takes higher quality pictures over the other cameras.
60 participants will be enrolled into this study. Participants need to have diabetic eye disease. This is a one-time study visit that lasts approximately 1 hour.
- Conditions
- Diabetic Retinopathy
- Being tested
- Topcon Camera, Optos Camera, Clarus Camera
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topcon CameraDiagnostic test
Standard 7 field imaging
Optos CameraDiagnostic test
Ultrawide field imaging
Clarus CameraDiagnostic test
Ultrawide field imaging
| Study group | Role | What they receive |
|---|---|---|
| Mild Non-Proliferative Diabetic Retinopathy (NPDR) | Presence of at least one retinal microaneurysm or hemorrhage as determined by clinician. Receives: Diagnostic Test: Topcon Camera; Diagnostic Test: Optos Camera; Diagnostic Test: Clarus Camera | |
| Moderate NPDR | Increasing hemorrhages and microaneurysms as well as cotton wool spots, venous beading (VB) or Intraretinal microvascular abnormalities (IRMA) to a mild degree as determined by clinician Receives: Diagnostic Test: Topcon Camera; Diagnostic Test: Optos Camera; Diagnostic Test: Clarus Camera | |
| Severe NPDR | "4-2-1" rule-that is, one has severe NPDR if hemorrhages or microaneurysms, or both, appear in all four retinal quadrants; venous beading appears in two or more retinal quadrants; or prominent IRMAs are present in at least one retinal quadrant as determined by clinician. Receives: Diagnostic Test: Topcon Camera; Diagnostic Test: Optos Camera; Diagnostic Test: Clarus Camera | |
| Proliferative Diabetic Retinopathy (PDR) | Neovascularization, either on or within one disc diameter (DD) of the optic disc (NVD) or elsewhere in the retina (NVE); a preretinal hemorrhage (PRH); or vitreous hemorrhage (VH) as determined by the clinician. Receives: Diagnostic Test: Topcon Camera; Diagnostic Test: Optos Camera; Diagnostic Test: Clarus Camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Level within the 7 standard fields of Clarus, Optos, and Standard 7 Field imaging and statistical comparison
The images captured within the 7 standard fields on each camera will be graded using the ETDRS severity scale. The total range of possible scores for severity level is from 10 (no DR) to 80 (PDR with vitreous hemorrhage); higher scores indicate increasing severity.
Details of ETDRS severity scale: 10-No DR, 15-Probable DR, no MAs, 20-MAs only, 35-Mild NPDR, 43,47-Moderate NPDR, 53-Severe NPDR, 60-PDR status post scatter photocoagulation, 61,65,71-PDR, 80-PDR with vitreous hemorrhage, 90,95-Ungradable.
ETDRS level agreement will be cross-tabulated and κ statistics calculated and assessed: <0.20, poor; 0.21-0.40, fair; 0.41-0.60, moderate; 0.61-0.80, substantial; and 0.81-1.00, almost perfect strength of agreement. Unweighted κ will be used to avoid potential bias by weighting. Agreement will also be tested for each severity level and k statistics analyzed.
Measured: 1 day
Number of Ungradable ETDRS Images within the 7 standard fields of Clarus, Optos, and Standard 7 Field imaging
The images captured within the 7 standard fields on each camera will be graded using the ETDRS severity scale. The proportion of ungradable images will be documented. On all tests, P < 0.05 will be considered significant, and nonparametric testing will be applied where appropriate.
Measured: 1 day
Secondary outcomes (4)
Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Level assessment of Clarus global, Optos global, and Standard 7 Field grading and statistical comparison
The images captured on each camera will be graded using the ETDRS severity scale. The total range of possible scores for severity level is from 10 (no DR) to 80 (PDR with vitreous hemorrhage); higher scores indicate increasing severity.
Details of ETDRS severity scale: 10-No DR, 15-Probable DR, no MAs, 20-MAs only, 35-Mild NPDR, 43,47-Moderate NPDR, 53-Severe NPDR, 60-PDR status post scatter photocoagulation, 61,65,71-PDR, 80-PDR with vitreous hemorrhage, 90,95-Ungradable.
ETDRS level agreement will be cross-tabulated and κ statistics calculated and assessed: <0.20, poor; 0.21-0.40, fair; 0.41-0.60, moderate; 0.61-0.80, substantial; and 0.81-1.00, almost perfect strength of agreement. Unweighted κ will be used to avoid potential bias by weighting. Agreement will also be tested for each severity level and k statistics analyzed.
Measured: 1 day
Number of Ungradable ETDRS Images within the Clarus global, Optos global, and Standard 7 Field grading
The images captured within the global fields of the Clarus and Optos cameras and the 7 standard field image will be graded using the ETDRS severity scale. The proportion of ungradable images will be documented. On all tests, P < 0.05 will be considered significant, and nonparametric testing will be applied where appropriate.
Measured: 1 day
Image quality assessment per image grader
The images captured on each camera for each participant will be assessed for quality using the Wisconsin Reading Center's 3-step confidence score. 1-High (image can be graded for both 7 field ETDRS and global severity level); 2-Adequate (image cannot be graded for global severity level); 3-Inadequate (image cannot be graded for ETDRS and global severity level).
Measured: 1 day
Reason Image Quality is compromised per image grader
If Wisconsin Reading Center Confidence score of 2 or 3, a reason is selected (technical, patient, both patient and technical, unknown, or N/A). Eyes with photographs classified as ungradable will be excluded from agreement tables.
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 Aug 2021
- Study start29 Sep 2021
- Primary completion7 Mar 2023
- Study completion7 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara Blodi, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022615
- Sponsor's protocol ID
- 2020-0977
- Other IDs
- A536000, Protocol Version 4-22-2021
- Acronym
- COCO
- Status last verified
- May 2023
- First submitted
- 20 Aug 2021
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Standard and Ultrawide Field Imaging Systems
- ClinicalTrials.gov ID
- NCT05022615
- Acronym / sponsor ID
- COCO / 2020-0977
- Conditions
- Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 7 Mar 2023 (actual)
- First posted
- 26 Aug 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.
The purpose of this study is to evaluate the quality of ocular images captured on 3 different cameras of patients with diabetic retinopathy. The study will determine whether diabetic retinopathy assessment is comparable between the cameras. The research is being done to see if a camera takes higher quality pictures over the other cameras.
60 participants will be enrolled into this study. Participants need to have diabetic eye disease. This is a one-time study visit that lasts approximately 1 hour.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mild Non-Proliferative Diabetic Retinopathy (NPDR) | – | Diagnostic Test: Topcon Camera, Diagnostic Test: Optos Camera, Diagnostic Test: Clarus CameraPresence of at least one retinal microaneurysm or hemorrhage as determined by clinician. |
| Moderate NPDR | – | Diagnostic Test: Topcon Camera, Diagnostic Test: Optos Camera, Diagnostic Test: Clarus CameraIncreasing hemorrhages and microaneurysms as well as cotton wool spots, venous beading (VB) or Intraretinal microvascular abnormalities (IRMA) to a mild degree as determined by clinician |
| Severe NPDR | – | Diagnostic Test: Topcon Camera, Diagnostic Test: Optos Camera, Diagnostic Test: Clarus Camera"4-2-1" rule-that is, one has severe NPDR if hemorrhages or microaneurysms, or both, appear in all four retinal quadrants; venous beading appears in two or more retinal quadrants; or prominent IRMAs are present in at least one retinal quadrant as determined by clinician. |
| Proliferative Diabetic Retinopathy (PDR) | – | Diagnostic Test: Topcon Camera, Diagnostic Test: Optos Camera, Diagnostic Test: Clarus CameraNeovascularization, either on or within one disc diameter (DD) of the optic disc (NVD) or elsewhere in the retina (NVE); a preretinal hemorrhage (PRH); or vitreous hemorrhage (VH) as determined by the clinician. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients (18 or older) with either Type 1 or Type 2 diabetes presenting at a single center of an ophthalmic retina practice for examination of diabetic retinopathy including color photography for standard medical care.
Key inclusion criteria (3 listed)
- any race
- Established diagnosis of diabetes.
- Willing to participate as evidenced by signing the written informed consent.
Key exclusion criteria (4 listed)
- Unable to tolerate ophthalmic imaging.
- Ocular is media not sufficiently clear to obtain technically acceptable ultrawide field images.
- History of panretinal laser photocoagulation or vitrectomy (history of anti-vascular endothelial growth factor treatment is not an exclusion criteria).
- Presences of confounding abnormalities such as age-related macular degeneration, retinal vein occlusion.
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 |
|---|---|---|
| Topcon CameraStandard 7 field imaging | Diagnostic test | Mild Non-Proliferative Diabetic Retinopathy (NPDR), Moderate NPDR, Proliferative Diabetic Retinopathy (PDR), Severe NPDR |
| Optos CameraUltrawide field imaging | Diagnostic test | Mild Non-Proliferative Diabetic Retinopathy (NPDR), Moderate NPDR, Proliferative Diabetic Retinopathy (PDR), Severe NPDR |
| Clarus CameraUltrawide field imaging | Diagnostic test | Mild Non-Proliferative Diabetic Retinopathy (NPDR), Moderate NPDR, Proliferative Diabetic Retinopathy (PDR), Severe NPDR |
Primary outcome
Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Level within the 7 standard fields of Clarus, Optos, and Standard 7 Field imaging and statistical comparison
Time frame: 1 day
The images captured within the 7 standard fields on each camera will be graded using the ETDRS severity scale. The total range of possible scores for severity level is from 10 (no DR) to 80 (PDR with vitreous hemorrhage); higher scores indicate increasing severity. Details of ETDRS severity scale: 10-No DR, 15-Probable DR, no MAs, 20-MAs only, 35-Mild NPDR, 43,47-Moderate NPDR, 53-Severe NPDR, 60-PDR status post scatter photocoagulation, 61,65,71-PDR, 80-PDR with vitreous hemorrhage, 90,95-Ungradable. ETDRS level agreement will be cross-tabulated and κ statistics calculated and assessed: <0.20, poor; 0.21-0.40, fair; 0.41-0.60, moderate; 0.61-0.80, substantial; and 0.81-1.00, almost perfect strength of agreement. Unweighted κ will be used to avoid potential bias by weighting. Agreement will also be tested for each severity level and k statistics analyzed.
Number of Ungradable ETDRS Images within the 7 standard fields of Clarus, Optos, and Standard 7 Field imaging
Time frame: 1 day
The images captured within the 7 standard fields on each camera will be graded using the ETDRS severity scale. The proportion of ungradable images will be documented. On all tests, P < 0.05 will be considered significant, and nonparametric testing will be applied where appropriate.
4 secondary outcomes
Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Level assessment of Clarus global, Optos global, and Standard 7 Field grading and statistical comparison
Time frame: 1 day
Number of Ungradable ETDRS Images within the Clarus global, Optos global, and Standard 7 Field grading
Time frame: 1 day
Image quality assessment per image grader
Time frame: 1 day
Reason Image Quality is compromised per image grader
Time frame: 1 day
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 22 May 2023.
- Individual participant dataSharing planned: No
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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.
Barbara Blodi, MD principal investigator
University of Wisconsin, Madison
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 Diabetic Retinopathy, run by University of Wisconsin, Madison at 1 site in United States.
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 3 inclusion and 4 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 May 2023. 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 United States. 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?
Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Level within the 7 standard fields of Clarus, Optos, and Standard 7 Field imaging and statistical comparison (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 May 2023.