Comparing 3 Imaging Systems

Completed

• Conditions: Diabetic Retinopathy

• Registration Number: NCT05022615
• Lead Sponsor: University of Wisconsin, Madison

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-20
• Study First Submitted QC: 2021-08-20
• Study First Posted: 2021-08-26
• Study Start: 2021-09-29
• Primary Completion: 2023-03-07
• Study Completion: 2023-03-07
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-18
• Last Update Posted: 2023-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Ungradable ETDRS Images within the 7 standard fields of Clarus, Optos, and Standard 7 Field imaging	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.
Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Level within the 7 standard fields of Clarus, Optos, and Standard 7 Field imaging and statistical comparison	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.

Secondary Outcome Measures

Name	Time	Method
Image quality assessment per image grader	1 day	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).
Number of Ungradable ETDRS Images within the Clarus global, Optos global, and Standard 7 Field grading	1 day	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.
Reason Image Quality is compromised per image grader	1 day	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.
Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Level assessment of Clarus global, Optos global, and Standard 7 Field grading and statistical comparison	1 day	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.

Trial Locations

Locations (1)

UW Health - University Station Clinic; 🇺🇸 Madison, Wisconsin, United States