Comparing 3 Imaging Systems (COCO)

University of Wisconsin (UW)

Status: Completed

Conditions: Diabetic Retinopathy

Treatments: Diagnostic Test: Topcon Camera; Diagnostic Test: Optos Camera; Diagnostic Test: Clarus Camera

Study type: Observational

Funder types: Other

Identifiers

NCT05022615

2020-0977

Protocol Version 4-22-2021 (Other Identifier)

A536000 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

51 participants in 4 patient groups

Mild Non-Proliferative Diabetic Retinopathy (NPDR)

Description:

Presence of at least one retinal microaneurysm or hemorrhage as determined by clinician.

Treatment:

Diagnostic Test: Optos Camera

Diagnostic Test: Clarus Camera

Diagnostic Test: Topcon Camera

Moderate NPDR

Description:

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

Treatment:

Diagnostic Test: Optos Camera

Diagnostic Test: Clarus Camera

Diagnostic Test: Topcon Camera

Severe NPDR

Description:

"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.

Treatment:

Diagnostic Test: Optos Camera

Diagnostic Test: Clarus Camera

Diagnostic Test: Topcon Camera

Proliferative Diabetic Retinopathy (PDR)

Description:

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.

Treatment:

Diagnostic Test: Optos Camera

Diagnostic Test: Clarus Camera

Diagnostic Test: Topcon Camera