Multicenter Diagnostic Clinical Performance Study For Aut... | NCT05471986

Studies
Multicenter Diagnostic Clinical Performance Study For Automated Detection of Diabetic Retinopathy

NCT05471986

Sponsor

Ural Telekomunikasyon Sanayi Ticaret Anonim Sirketi

Status

Unknown status

Last Update Posted

Nov 29, 2023Actual

Enrollment

900Estimated

Phase

Not provided

Conditions

Diabetic Retinopathy

Interventions

Color Fundus Photography/Non-Mydriatic Opthalmic Cameras

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2024Estimated

Primary Completion Date

Dec 1, 2024Estimated

Completion Date

Dec 1, 2024Estimated

First Submitted Date

Jul 20, 2022

First Submission Date that Met QC Criteria

Jul 20, 2022

First Posted Date

Jul 25, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 28, 2023

Last Update Posted Date

Nov 29, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

900Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Color Fundus Photography/Non-Mydriatic Opthalmic Cameras	Device	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity and Specificity of EyeCheckup to detect more than mild diabetic retinopathy		1 visit (1 day)
Sensitivity and Specificity of EyeCheckup to detect vision-threatening diabetic retinopathy		1 visit (1 day)

Secondary Outcomes

Measure	Description	Time Frame
Positive Predictive Value		1 visit (1 day)
Negative Predictive Value		1 visit (1 day)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Diabetic Patients of 22 years or older

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Rim Khazhin	Contact	+905357666383		trials@eye-checkup.com

Name	Affiliation	Role
Rim Khazhin	Ural Telekom	Study Chair

IPD Sharing Statement Module

Plan to Share IPD

Description

No individual data will be shared.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D003925	Diabetic Angiopathies
D014652	Vascular Diseases