Comparing 3 Imaging Systems

Diabetic Retinopathy Clinical Trial

— COCO  

Official title:

Comparison of Standard and Ultrawide Field Imaging Systems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05022615
• Other study ID #: 2020-0977
• Secondary ID: A536000Protocol
• Status: Completed
• Start date: September 29, 2021
• Est. completion date: March 7, 2023

Study information

• Verified date: May 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: March 7, 2023
• Est. primary completion date: March 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Retinopathy

Intervention

Diagnostic Test:
• Topcon Camera
Standard 7 field imaging
• Optos Camera
Ultrawide field imaging
• Clarus Camera
Ultrawide field imaging

Locations

Country	Name	City	State
United States	UW Health - University Station Clinic	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ? 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 ? will be used to avoid potential bias by weighting. Agreement will also be tested for each severity level and k statistics analyzed.	1 day
Primary	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	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 ? 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 ? will be used to avoid potential bias by weighting. Agreement will also be tested for each severity level and k statistics analyzed.	1 day
Secondary	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
Secondary	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
Secondary	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