RETeval Study for Diabetic Retinopathy

NCT01950663 | Completed Results

• 2 other identifiers: 3032R44EY021121
• Study Type: interventional
• Target: 468
• Locations: 1 country
• Sites: 2

Brief Summary

RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy. The purpose of this study is to calibrate RETeval, and then measure its ability to detect vision threatening diabetic retinopathy. Early Treatment Diabetic Retinopathy Study (ETDRS) 7-field, dilated, stereo, color fundus photography, read according to the ETDRS protocol, will be used as the gold standard.

Conditions

Diabetic Retinopathy

Keywords

Diagnostic Equipment; Validation Studies

Outcome Measures

Primary Outcomes (1)

• Per Patient Referral Accuracy

  Accuracy will be reported as count of participants with referral status correctly identified, sensitivity, and specificity, with ETDRS photography and reading as the gold standard.

  During a single visit, implicit time, measured by the RETeval device, and ETDRS photography, will be performed to support the analysis of the accuracy of the RETeval device.

Study Arms (1)

RETeval

EXPERIMENTAL

RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light.

Device: RETeval

Interventions

RETeval DEVICE

RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light.

RETeval

Eligibility Criteria

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

You may qualify if:

• Patients diagnosed with diabetes and treated with at least one oral hypoglycemic medication or insulin
• Eighteen years or older

You may not qualify if:

• History of photosensitive epilepsy
• Previous laser or drug treatment for diabetic retinopathy or macular edema
• Eye diseases other than diabetic retinopathy or macular edema that, in the opinion of the recruiting ophthalmologist, may affect the electroretinogram or result in ungradable Early Treatment Diabetic Retinopathy Study Protocol images.
• Inability or unwillingness of the subject or legal guardian/representative to give written informed consent

Sponsors & Collaborators

• Inoveon Corporation: lead
• LKC Technologies, Inc.: collaborator
• National Eye Institute (NEI): collaborator

Study Sites (2)

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

Location

Oklahoma City VA Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

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

Results Point of Contact

• Title: Dr. Stephen R. Fransen
• Organization: Dean McGee Eye Institute / University of Oklahoma Health Sciences Center

stephen-fransen@dmei.org

405-271-1092

Study Officials

• Stephen R Fransen, MD

  Inoveon Corporation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Medical Officer

Study Record Dates

• First Submitted: September 5, 2013
• First Posted: September 25, 2013
• Study Start: September 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 12, 2017
• Results First Posted: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)