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Assessment of Hypertensive Retinopathy Using Neural Network "RetinAIcheck"

Assessment of Hypertensive Retinopathy Using Keith Wagener Barker's Classification, Based on Neural Network "RetinAIcheck"

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07471971
Enrollment
755
Registered
2026-03-13
Start date
2021-03-11
Completion date
2026-02-26
Last updated
2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertensive Retinopathy

Keywords

convolutional neural network, hypertensive retinopathy

Brief summary

The current study is aimed at estimating the diagnostic effectiveness of a developed neural network "RetinAIcheck" in grading the severity of hypertensive retinopathy in patients of the Russian population. The training data set was obtained from an open source and relabeled by seven independent retina specialists, the sample size was 30,000 fundus photographs. The test sample included 755 patients (1374 eyes). Among the 1.374 eyes, 94 were without HR (class 0), 330 had class 1, 660 had class 2, 280 had class 3, and 10 had class 4 HR.The reference standard was the result of independent grading of HR stage by two ophthalmologists, controversial clinical cases were evaluated with the involvement of a third ophthalmologist.

Interventions

DIAGNOSTIC_TESTConvolutional neural network "RetinAIcheck"

A convolutional neural network is a medical decision support system that processes digital fundus photographs obtained during mydriasis and determines the probability of the presence/absence of hypertensive retinopathy and it's grading due to Keith Wagener Barker's classification.

Sponsors

I.M. Sechenov First Moscow State Medical University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

\- Patients with and without a diagnosis of arterial hypertension, based on medical records

Exclusion criteria

* anophthalmia, * optic nerve atrophy, * eyeball injuries, * age-related macular degeneration, * central serous chorioretinopathy, * central serous chorioretinitis, * clouding of the optical media of the eye, which affects the quality of the image.

Design outcomes

Primary

MeasureTime frameDescription
AccuracyThe ability to correctly identify the presence or absence of conditionThe ability of a test to correctly identify the proportion of true positive cases

Secondary

MeasureTime frameDescription
SensitivityFebruary 2026The ability of a test to correctly identify the proportion of true positive cases
SpecificityFebruary 2026The ability of a test to correctly identify the proportion of true negative cases
Positive predictive valueFebruary 2026The probability that a person who tests positive for the condition actually has that one
Negative predictive valueFebruary 2026The probability that a person who tests negative for the condition truly does not have it
AUROC, area under the ROC curve (one-versus-rest)February 2026An average metric used to evaluate multi-class classification models by computing the Area Under the ROC Curve for each class separately against all other classes and then averaging the results
Quadratically weighted kappaFebruary 2026A statistical measure that evaluates the level of agreement between two raters or outcomes on an ordinal scale, penalizing errors based on the squared distance between categories

Countries

Russia

Contacts

PRINCIPAL_INVESTIGATORPhilipp Yu Kopylov, Prof.

Sechenov First Moscow State Medical University (Sechenov University)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026