Comparing 3 Imaging Systems (COCO)

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Retinopathy
• Intervention / Treatment: Diagnostic test: Topcon Camera; Diagnostic test: Optos Camera; Diagnostic test: Clarus Camera

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • UW Health - University Station Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• any race
• Established diagnosis of diabetes.
• Willing to participate as evidenced by signing the written informed consent.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mild Non-Proliferative Diabetic Retinopathy (NPDR); Presence of at least one retinal microaneurysm or hemorrhage as determined by clinician.	Diagnostic test: Topcon Camera; Standard 7 field imaging; Diagnostic test: Optos Camera; Ultrawide field imaging; Diagnostic test: Clarus Camera; Ultrawide field imaging
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	Diagnostic test: Topcon Camera; Standard 7 field imaging; Diagnostic test: Optos Camera; Ultrawide field imaging; Diagnostic test: Clarus Camera; Ultrawide field imaging
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.	Diagnostic test: Topcon Camera; Standard 7 field imaging; Diagnostic test: Optos Camera; Ultrawide field imaging; Diagnostic test: Clarus Camera; Ultrawide field imaging
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.	Diagnostic test: Topcon Camera; Standard 7 field imaging; Diagnostic test: Optos Camera; Ultrawide field imaging; Diagnostic test: Clarus Camera; Ultrawide field imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	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.	1 day

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Barbara Blodi, MD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2021
• Primary Completion (Actual): March 7, 2023
• Study Completion (Actual): March 7, 2023

Study Registration Dates

• First Submitted: August 20, 2021
• First Submitted That Met QC Criteria: August 20, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: 2020-0977; A536000 (Other Identifier: UW Madison); Protocol Version 4-22-2021 (Other Identifier: University of Wisconsin-Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes