N/A
N=900
Detection and Classification of Diabetic Retinopathy From Posterior Pole Images With A Deep Learning Model
Diabetic Retinopathy · Diabetic Eye Problems · Diabetic Macular Edema
Bottom Line
View on ClinicalTrials.gov: NCT04805541 ↗Enrolled (actual)
900
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Sensitivity(mtmDR) — 90.48; 95.65; 95.19 percentage of true positives
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Color Fundus Photography (Procedure); Mydriatic Agent (Drug); EyeCheckup - AI Based DR Screening (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ural Telekomunikasyon Sanayi Ticaret Anonim Sirketi
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity(mtmDR) |
90.48; 95.65; 95.19 | — |
| PRIMARY Sensitivity(vtDR) |
95.12; 96.00; 96.34 | — |
| PRIMARY Specificity(mtmDR) |
97.21; 95.92; 95.93 | — |
| PRIMARY Specificity(vtDR) |
98.82; 96.34; 95.93 | — |
| SECONDARY Diagnosability |
96.57; 100; 100 | — |
| SECONDARY Non-Dilated EyeCheckup Usage |
62.24; 68.90; 78.46 | — |
Summary
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04805541). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.