AutoDx-DR Prospective Clinical Validation Study Protocol

NCT04627272 | Unknown FDA Device

• 1 other identifier: 60095127
• Study Type: interventional
• Target: 1,539
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study, we will prospectively evaluate the accuracy of a deep-learning based software algorithm in the detection of diabetic retinopathy from 60° wide single-field retinal fundus images.

Conditions

Diabetic Retinopathy

Keywords

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (2)

• Sensitivity

  The ability of AutoDX-DR to correctly identify those with the disease (true positive rate)

  Each subject will only have one day study visit and will provide the AutoDX-DR and gold standard reading during their one visit.

• Specificity

  The ability of AutoDX-DR to correctly identify those without the disease (true negative rate)

  Each subject will only have one day study visit and will provide the AutoDX-DR and gold standard reading during their one visit.

Study Arms (1)

AutoDX and Gold Standard

EXPERIMENTAL

A licensed clinician will obtain 60° wide single-field retinal fundus images from subjects who are diabetic patients in primary care environments (i.e. non-eye care settings, such as internal medicine, family medicine, and endocrinology). The fundus images will be uploaded to the RetinaVue Network software using the AutoDx-DR with Over-read modality, where images are transmitted to both AutoDx-DR and a remote ophthalmologist. Subjects participating in this study will undergo further retinal fundus imaging: four mydriatic, stereoscopic 45° field of view (4W) retinal images and spectral domain optical coherence tomography (SD-OCT) captured with the Reference Standard Camera

Device: AutoDX-DR

Interventions

AutoDX-DR DEVICE

AutoDx-DR provides basic image interpretation for the detection of DR and diabetic macular edema (DME) and a Refer or Not Refer recommendation.

AutoDX and Gold Standard

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A documented diagnosis of diabetes mellitus in accordance with the criteria established by the American Diabetes Association (ADA)7 as indicated by at least one of the following:
• Hemoglobin A1c (HbA1c) \> 6.5%
• Fasting Plasma Glucose (FPG; period of fasting must be at least 8 hours) \> 126 mg/dL (7.0 mmol/L)
• Oral Glucose Tolerance Test (OGTT) with 2-hour plasma glucose \>200 mg/dL (11.1 mmol/L), using the equivalent of an oral 75 g anhydrous glucose dose dissolved in water o Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dL (11.1 mmol/L)
• years of age or older
• Ability to understand the study and sign the informed consent

You may not qualify if:

• A documented diagnosis of more than mild diabetic retinopathy in the patient record.
• o More than mild diabetic retinopathy shall be defined as moderate NPDR, severe NPDR, proliferative diabetic retinopathy (PDR) or any level of DME; or a documented diabetic eye exam report indicating more than microaneurysms \[i.e. presence of intraretinal hemorrhages, venous beading, intraretinal microvascular abnormalities (IRMA,) neovascularization or DME.\]
• They report having severe vision loss in both eyes.
• They report a history of laser treatment or surgery of the retina.
• They report that they are currently receiving treatment for DR or DME.
• They report a diagnosis of angle closure glaucoma.
• They report hypersensitivity to light which makes retinal imaging uncomfortable.
• They are currently pregnant or breastfeeding.
• They report that they have an iris supported intraocular lens or anterior chamber intraocular lens associated with a previous cataract surgery.
• They had a previous pupilloplasty surgery.

Sponsors & Collaborators

• Hill-Rom: lead
• Rho, Inc.: collaborator
• ClinEdge: collaborator

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Antonio Piñero-Piloña, MD

  Diabetes Care Center

  PRINCIPAL INVESTIGATOR

• Joseph Woolley, MD

  Southwest Internal Medicine

  PRINCIPAL INVESTIGATOR

• Keila Hoover, MD

  Hoover Family Medicine

  PRINCIPAL INVESTIGATOR

• Quang Vo, MD

  Dr. Steven Barag, DO

  PRINCIPAL INVESTIGATOR

• Peter Mattar, MD

  Dr. Peter N. Mattar, MD

  PRINCIPAL INVESTIGATOR

• Efrain Soto, MD

  Park Lakes Family Medicine

  PRINCIPAL INVESTIGATOR

• Harish Thakkar, MD

  Southwest Medical Clinic

  PRINCIPAL INVESTIGATOR

• Luis Gonzalez-Orozco, MD

  Clinic of Luis Gonzalez

  PRINCIPAL INVESTIGATOR

• Jennifer Bellucci-Jackson, MD

  Family Medicine Specialists

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Downs

CONTACT

9893394131; Elizabeth.Downs@hillrom.com

Lindsay E Downing

CONTACT

8043070924; lindsay.downing@hillrom.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a study to determine the accuracy of AutoDX. All eligible study participants will have a retinal fundus image taken which is then uploaded to the RetinaVue Network. Subjects will also undergo further retinal fundus imaging: four mydriatic, stereoscopic 45° field of view (4W) retinal images and spectral domain optical coherence tomography (SD-OCT) captured with the Reference Standard Camera.

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 13, 2020
• Study Start: December 1, 2020
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share