Clinical trial NCT04612868: Efficacy and Safety of AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Fundus Images
Official title: Pivotal Prospective Clinical Trial to Demonstrate the Efficacy and Safety of AEYE-DS Software Device for Automated Diabetic Retinopathy Detection From Digital Fundoscopic Images
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Diabetic Retinopathy
Lead sponsor: AEYE Health Inc
Sponsor class: INDUSTRY
First posted: 2020-11-03
Enrollment: 531
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: AEYE-DS is a software device developed to increase compliance with diabetic retinopathy screening by automatically detecting more-than-mild diabetic retinopathy from digital fundus images using Artificial Intelligence (AI)-based software. This study has been designed to validate the safety and efficacy of the device at primary care and other point of care sites.


Eligibility criteria: Inclusion Criteria:

* Age ≥22
* Male or female
* Documented diagnosis of diabetes mellitus, meeting the criteria established by the American Diabetes Association (ADA) and World Health Organization (WHO).
* Understand the study and volunteer to sign the informed consent

Exclusion Criteria:

* Uncorrectable vision loss (e.g., with the use of eyeglasses), blurred vision, or floaters.
* Diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion.
* History of laser treatment of the retina or injections into either eye, or any history of retinal surgery.
* Currently participating in another investigational eye study and actively receiving investigational product for Diabetic Retinopathy (DR) or Diabetic Macular Edema (DME).
* Participant has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation).
* Participant is contraindicated for imaging by fundus imaging systems used in the study:

  1. Participant is hypersensitive to light
  2. Participant recently underwent photodynamic therapy (PDT)
  3. Participant is taking medication that causes photosensitivity
  4. Participant has a history of angle-closure glaucoma or narrow anterior chamber angles

Primary outcomes:
measure: Sensitivity and Specificity, Based on Two Macula-centered Images (One Image From Each Eye of the Patient)
timeFrame: 1 day
Secondary outcomes:
measure: Sensitivity and Specificity, Based on Four Images (One Macula Centered Image and One Optic Disc Centered Image Per Eye)
timeFrame: 1 day
measure: Imageability, Based on Two Macula-centered Images (One Image From Each Eye of the Patient)
timeFrame: 1 day
measure: Imageability, Based on Four Images (One Macula Centered Image and One Optic Disc Centered Image Per Eye)
timeFrame: 1 day
Other outcomes:
Locations:
city: Louisville
country: United States
facility: The Eye Care Institute
state: Kentucky
Study officials:
References: