Comparison of Standard and Ultrawide Field Imaging Systems
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Number of Ungradable ETDRS Images within the 7 standard fields of Clarus, Optos, and Standard 7 Field imaging
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Image quality assessment per image grader(1 day)
- Number of Ungradable ETDRS Images within the Clarus global, Optos global, and Standard 7 Field grading(1 day)
- Reason Image Quality is compromised per image grader(1 day)
- Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Level assessment of Clarus global, Optos global, and Standard 7 Field grading and statistical comparison(1 day)