Multicenter Diagnostic Clinical Performance Study For Automated Detection of Diabetic Retinopathy

Diabetic Retinopathy Clinical Trial

Official title:

Multicenter Diagnostic Clinical Performance Study For Automated Detection of Diabetic Retinopathy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05471986
• Other study ID #: EC-2023DR
• Status: Not yet recruiting
• Start date: August 1, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2023
• Source: URAL Telekomunikasyon San. Trade Inc.
• Contact: Rim Khazhin
• Phone: +905357666383
• Email: trials[@]eye-checkup.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a retrospective study to assess the efficacy and accuracy of the EyeCheckup software in screening for diabetic retinopathy in healthcare settings.

Description:

This is a clinical diagnostic performance study for EyeCheckup with data obtained consecutively at multiple geographically different sites within the US population. These sites include all healthcare settings with a trained ophthalmic camera operator using non-mydriatic cameras that are compatible with EyeCheckup. Moreover, primary endpoints are devised that will be used to validate EyeCheckup to diagnose DR in the primary care and eye care settings. During this color fundus images representing either 4 wide field or 7 standard fields of view will be graded by a qualified professional for diabetic retinopathy according to ETDRS on DRSS scale. The human grading output will be compared with diagnosis generated for diabetic retinopathy by AI software. A comparison of both these grades will be used to determine sensitivity and specificity for the EyeCheckup software for screening for diabetic retinopathy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 900
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• A diagnosis of either diabetes type 1 or diabetes type 2

• 22 years of age or older

• Patients Fundus images must include at least 1 macula centered and 1 optic disc nerve centered image

• All the subjects must be sequentially photographed meaning no omissions of data between a certain time frame by the sites providing images to ensure consecutive selection

• No history of any other retinal vascular disease, glaucoma, or another disease that may affect the appearance of the retina or optic disc (refractive error and ocular surface disease are allowed)

Subject with image taken by color fundus photography that meets the following requirements:

• The resolution of image is 1024×1024 pixels or higher

• The ability to provide a 7 standard or 4 wide field of view

• Must obtained from either Topcon NW400 or Cannon Model CR-2 AF or CR-2 Plus AF or Optomed Aurora Cameras along with the following data: their age, ethnicity and gender, patient ocular history as evaluated of verified by the clinical sites where data is obtained

Exclusion Criteria:

• No diagnosis of either diabetes type 1 or diabetes type 2

• The macula, optic nerve, or other part in the image of color fundus photography is unclear to determine the disease condition as judged by the certified ophthalmologist who is grading the images.

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Device:
• Color Fundus Photography/Non-Mydriatic Opthalmic Cameras
Subjects will have underwent Fundus Photography using FDA approved non-mydriatic fundus cameras compatible with EyeCheckup which are either TOPCON NW400, CANNON CR2, CANNON CR2 Plus or OPTOMED AURORA IQ

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
URAL Telekomunikasyon San. Trade Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and Specificity of EyeCheckup to detect more than mild diabetic retinopathy		1 visit (1 day)
Primary	Sensitivity and Specificity of EyeCheckup to detect vision-threatening diabetic retinopathy		1 visit (1 day)
Secondary	Positive Predictive Value		1 visit (1 day)
Secondary	Negative Predictive Value		1 visit (1 day)