Comparing 3 Imaging Systems
COCO
Comparison of Standard and Ultrawide Field Imaging Systems
3 other identifiers
observational
51
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2021
CompletedFirst Posted
Study publicly available on registry
August 26, 2021
CompletedStudy Start
First participant enrolled
September 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 7, 2023
CompletedMay 22, 2023
May 1, 2023
1.4 years
August 20, 2021
May 18, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Level assessment of Clarus global, Optos global, and Standard 7 Field grading and statistical comparison
1 day
Number of Ungradable ETDRS Images within the Clarus global, Optos global, and Standard 7 Field grading
1 day
Image quality assessment per image grader
1 day
Reason Image Quality is compromised per image grader
1 day
Study Arms (4)
Mild Non-Proliferative Diabetic Retinopathy (NPDR)
Presence of at least one retinal microaneurysm or hemorrhage as determined by clinician.
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
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.
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.
Interventions
Standard 7 field imaging
Ultrawide field imaging
Ultrawide field imaging
Eligibility Criteria
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.
You may qualify if:
- any race
- Established diagnosis of diabetes.
- Willing to participate as evidenced by signing the written informed consent.
You may not qualify if:
- Unable to tolerate ophthalmic imaging.
- Ocular is media not sufficiently clear to obtain technically acceptable ultrawide field images.
- Presences of confounding abnormalities such as age-related macular degeneration, retinal vein occlusion.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UW Health - University Station Clinic
Madison, Wisconsin, 53705, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara Blodi, MD
University of Wisconsin, Madison
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2021
First Posted
August 26, 2021
Study Start
September 29, 2021
Primary Completion
March 7, 2023
Study Completion
March 7, 2023
Last Updated
May 22, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share