Pivotal Trial to Assess the Clinical Performance of Ophthal-360 for the Detection of Diabetic Retinopathy

Ophthalytics, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID

Study Details

Study Description

Brief Summary

Multicenter, prospective, study to assess the performance of the Ophthal-360 platform in the diagnosis of more-than-mild Diabetic Retinopathy (mtmDR) in diabetic patients with no previous diagnosis of DR.

Condition or Disease Intervention/Treatment Phase
  • Device: Fundus Photography

Detailed Description

This is a multicenter, prospective study in which 500 adult subjects at risk for DR but never before diagnosed who satisfy all entry criteria will be enrolled at up to 5 primary care sites.

An additional sub-study will be performed on 30 subjects to assess the precision of the algorithm in detecting DR by imaging these subjects multiple times to demonstrate intra- and inter-operator reliability of the algorithm.

All enrolled subjects will undergo retinal imaging by a novice operator with no experience using the fundus cameras listed. Images from each retinal imaging device will be saved to a computer and uploaded to the server for evaluation by the Ophthal-360 service. A report will be generated and archived for the results of each image.

After imaging by the novice operator, each patient will then have their eyes photographed by a professional fundus photographer using standard mydriatic and OCT imaging for macular edema evaluation. These images will be sent to a Fundus Photography Reading Center for final determination and diagnosis. Patients will received the result of the FPRC evaluation, but not be provided the reports generated by the software.

A comparison between the FPRC determination and the software generated report will be performed to evaluate the analytical performance of the algorithm.

Study Design

Study Type:
Anticipated Enrollment :
500 participants
Observational Model:
Time Perspective:
Official Title:
Pivotal Trial to Assess the Clinical Performance of Ophthal-360
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Device: Color Fundus Photography with Non-Mydriatic and Mydriatic Cameras

Device: Fundus Photography
Subjects will undergo Fundus Photography using FDA approved non-mydriatic fundus cameras and mydriatic camera with OCT

Outcome Measures

Primary Outcome Measures

  1. Sensitivity of the Ophthal-360 Software to detect diabetic retinopathy in fundus images [1 day]

    Performance of the Ophthal-360 Software when compared to results of evaluation of fundus photographs by qualified experts.

  2. Specificity of the Ophthal-360 Software to detect diabetic retinopathy in fundus images [1 day]

    Performance of the Ophthal-360 Software when compared to ground truth evaluation of fundus photographs by qualified experts.

Eligibility Criteria


Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  1. Aged at least 22 years old.

  2. A documented history of Diabetes Mellitus, defined as any of the following:

  • Hemoglobin A1c (HbA1c) ≥ 6.5% based on repeated assessments

  • Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L) based on repeated assessments

  • Oral Glucose Tolerance test with 2-hour plasma glucose ≥ 200 mg/dL (11.1mmol/L) using equivalent of 75g anhydrous glucose dose in water.

  • Symptoms of hyperglycemia or hyperglycemic crisis with random plasma glucose ≥ 200mg/dL (11.1 mmol/L)

  • Criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA).

  1. Willing to undergo fundus photography by up to 4 different methods and/or cameras.

  2. Has signed a written informed consent form prior to study participation.

Exclusion Criteria:
  1. Diagnosed with uncorrectable vision loss (e.g., with the use of eyeglasses), blurred vision, or floaters.

  2. Diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion.

  3. Has a positive history for laser treatment of the retina or injections into either eye, or any history of retinal surgery.

  4. Is currently participating in another investigational eye study and actively receiving investigational product for DR or Diabetic Macular Edema (DME).

  5. 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).

  6. Is contraindicated for imaging by fundus imaging systems used in the study:

  • hypersensitive to light

  • recently (within 6 months) underwent photodynamic therapy (PDT)

  • taking medication that causes photosensitivity

  • positive history for angle-closure glaucoma or narrow anterior chamber angles

Contacts and Locations


No locations specified.

Sponsors and Collaborators

  • Ophthalytics, Inc.


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Ophthalytics, Inc.
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • CD0001
First Posted:
Apr 10, 2023
Last Update Posted:
Apr 10, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Product Manufactured in and Exported from the U.S.:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 10, 2023