Detection and Classification of Diabetic Retinopathy From Posterior Pole Images With A Deep Learning Model

The duration of diabetes is directly related to eye complications. Diabetic retinopathy affects 80 percent of those who have had diabetes for 20 years or more. At least 90% of new cases can be reduced with proper treatment and monitoring of the eyes. The longer a person has diabetes, the more likely it is to develop diabetic retinopathy. Each year in the United States, diabetic retinopathy accounts for 12% of all new cases of blindness. It is also the leading cause of blindness in people between the ages of 20 and 64. The most important complication of diabetes leading to vision loss is diabetic retinopathy. Depending on this, macular edema, bleeding into the retina and vitreous,neovascular glaucoma can cause blindness.

Diabetic retinopathy (DR) is a leading cause of vision-loss globally. Of an estimated 285 million people with diabetes mellitus worldwide, approximately one third have signs of DR and of these, a further one third of DR is vision-threatening DR, including diabetic macular edema (DME). Diabetic retinopathy is a retinal disease that can often be stopped with early diagnosis, but if neglected, it can lead to severe vision loss, including permanent blindness. Diabetes has high morbidity and there are millions of people who should be screened for diabetic retinopathy (DR). Annual eye screening is recommended for all diabetic patients since vision loss can be prevented if DR is diagnosed in its early stages. Currently, the number of clinical personnel trained for DR screening is less than that needed to screen a growing diabetic population. Therefore, the automatic DR screening system will be able to screen more diabetic patients and diagnose them early.

EyeCheckup is an automated retinal screening device designed automatically analyze color fundus photographs of diabetic patients to identify patients with referable or vision threatening DR. This study is designed to assess the safety and efficacy of EyeCheckup.

The study is a single center study to determine the sensitivity and specificity of EyeCheckup to diabetic retinopathy. EyeCheckup is an automated software device that is designed to analyze ocular fundus digital color photographs taken in frontline primary care settings in order to quickly screen for diabetic retinopathy (DR).

Study Overview

• Status: Completed
• Conditions: Diabetic Retinopathy; Diabetic Macular Edema; Diabetic Eye Problems
• Intervention / Treatment: Drug: Mydriatic Agent; Procedure: Color Fundus Photography; Device: EyeCheckup - AI Based DR Screening

Detailed Description

This is a prospective study to assess the safety and efficacy of EyeCheckup in screening for DR.

This study was carried out in a single center at Akdeniz University Faculty of Medicine with primary endpoints to determine the sensitivity and specificity of EyeCheckup to diabetic retinopathy in the primary care setting.

Methods and tools to be used in the study:

• Fundus photography with non-mydriatic camera and classification of diabetic retinopathy with artificial intelligence algorithm,
• Evaluation of seven field dilated fundus images by retina specialists and comparison of results for clinical validation of the system.

Clinical and laboratory tests to be performed:

• Fundus photography with a non-mydriatic camera. In this study, no invasive procedure is applied to the patient, the retinal photograph will be taken with a special digital camera called a fundus camera. In patients whose non-mydriatic image cannot be obtained, tropicamide drops will be instilled to dilate the pupil, and then photographs will be taken.
• Pupil dilation will be achieved by instilling Tropicamide drops in both eyes of the patient, and then 4 quadrant photographs of both eyes will be taken with a mydriatic fundus camera.

After exclusions, this study will enroll up to 900 subjects who are diagnosed with diabetes by the endocrinology polyclinic and meet the eligibility criteria. Participants who meet the eligibility criteria will be recruited after obtaining written informed consent from primary health care providers. Subjects will undergo fundus photography per, Food and Drug Administration (FDA) cleared, ophthalmic cameras (product code: HKI). Images will be taken according to a specific EyeCheckup imaging protocol provided to the ophthalmic camera operator and then analyzed by the EyeCheckup device.

The photography protocol consists of two images of the ocular fundus (one optic disc nerve centered, one macula centered), obtained from both eyes of enrolled participants.

After the retinal images taken from ophthalmic cameras (product code: HKI), images are analyzed with EyeCheckup and a scan report is prepared. If it is necessary to enlarge the pupils, eye enlarging eye drops are applied and wait 15-30 minutes. This information is noted. DR is diagnosed by examination by a retina specialist with the captured images. EyeCheckup success rate is calculated by comparing both reports.

• Study Type: Observational
• Enrollment (Actual): 900

Contacts and Locations

Study Locations

• Turkey
  • Antalya, Turkey, 07070
    • Akdeniz University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

• Primary care clinic - invitation to volunteer,
• Diabetic Patients
• Eighteen years of age or older
• Have been referred to an ophthalmologist for eye examination to screen for diabetic retinopathy

• Diseases Polyclinic with the diagnosis of diabetes and were able to view the posterior polar region of the eye with an ophthalmic camera.

  900 volunteer patients who applied to the Akdeniz University Endocrinology and Metabolic

Description

Inclusion Criteria:

• A diagnosis of diabetes mellitus
• Understanding of study and provision of written informed consent
• 18 years of age or older
• No history of any other retinal vascular disease, glaucoma, or other disease that may affect the appearance of the retina or optic disc (refractive error and ocular surface disease are allowed)
• Other than cataract surgery, no history of intraocular surgery, ocular laser treatments for any retinal disease, or ocular injections for diabetic macular edema or proliferative disease No media opacity precluding good retinal photography

Exclusion Criteria:

• No diagnosis of diabetes mellitus
• Potential subject cannot understand study or informed consent
• A history of retinal vascular disease other than diabetic retinopathy that may affect the appearance of the retina or optic disc
• Previous intraocular surgery including cataract; previous laser to the retina; or previous intraocular injections for the treatment of diabetic retinopathy
• Pregnant women or women with gestational diabetes mellitus
• A media opacity in either eye that is severe enough to preclude good retinal photography
• Permanent vision impairment in one or both eyes
• The participant is contraindicated for imaging with fundus imaging systems used in the study:
• Participant is hypersensitive to light
• Participant recently received photodynamic therapy (PDT)
• Participant uses drugs that cause photosensitivity

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity(mtmDR)	Sensitivity for detecting more than mild diabetic retinopathy	1 visit (1 day)
Sensitivity(vtDR)	Sensitivity for detecting vision threatening diabetic retinopathy	1 visit (1 day)
Specificity(mtmDR)	Specificity for detecting more than mild diabetic retinopathy	1 visit (1 day)
Specificity(vtDR)	Specificity for detecting vision threatening diabetic retinopathy	1 visit (1 day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosability	percentage of patients with image quality sufficient for EyeCheckup to produce an output to patients with image quality sufficient for the clinical reference standard to produce an output	1 Day
Non-Dilated EyeCheckup Usage	Percentage of participants for whom Non-Dilated Images were sufficient to use EyeCheckup	1 Day

Collaborators and Investigators

• Sponsor: URAL Telekomunikasyon San. Trade Inc.
• Collaborators: Akdeniz University
• Investigators: Principal Investigator: A Burak Bilgin, Assoc. Prof., Instructor, Retinal Surgeon, Academic Advisor

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): July 4, 2022
• Study Completion (Actual): July 4, 2022

Study Registration Dates

• First Submitted: March 15, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): July 15, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Degeneration; Macular Degeneration; Retinal Diseases; Diabetic Retinopathy; Macular Edema; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Mydriatics; Tropicamide
• Other Study ID Numbers: EC-2021DR-TR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual data will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No