Development of an Optimal Algorithm for the Management of Patients With Retinal Pigment Epithelium Detachment in Neovascular Age-related Macular Degeneration Using Artificial Intelligence

April 11, 2023 updated by: Viktoria Myasnikova, The S.N. Fyodorov Eye Microsurgery State Institution

Development of an Algorithm for Predicting Anatomical and Functional the Results of Therapy With Angiogenesis Inhibitors in Patients With Retinal Pigment Epithelium Detachments in Neovascular Age-related Macular Degeneration, Based on Primary Optical Coherence Tomography of the Macular Zone and Clinical Data.

The study involves the development of an algorithm for predicting anatomical and functional results of therapy with angiogenesis inhibitors in patients with retinal pigment epithelium detachments in neovascular age-related macular degeneration, based on primary optical coherence tomography of the macular zone and clinical data.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients were divided into 3 groups according to the results of therapy: adhesion of detachment, lack of adherence to detachment, rupture of detachment. For these groups, OCT images of the macular zone with maximum detachment before therapy are selected. These images, along with other clinical parameters, are input to the algorithm. The result is one of the 3 treatment outcomes listed above. The methods that will be used to develop the algorithm include methods for processing and transforming data, deep machine learning, metrics for calculating the accuracy of algorithms.

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Krasnodar, Russian Federation, 350012
        • The S.N. Fyodorov Eye Microsurgery State Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients with retinal pigment epithelium detachments with age-related neovascular macular degeneration

Description

Inclusion criteria:

  • Linear B - scan through the macular area with the longest detachment
  • Other pathologies

Exclusion criteria:

  • Images without detachment
  • Images on which it is possible to diagnose the need for therapy only in the presence of additional factors not considered in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
adhesion
the group in which the adhesion of neuroepithelial detachment was observed after Anti-vascular endothelial growth factor therapy
Procedure: Anti-vascular endothelial growth factor therapy
0.05 ml anti-VEGF, intravitreal, monthly
Other Names:
  • anti-VEGF
no adhesion
group in which there was no adherence of neuroepithelial detachment after Anti-vascular endothelial growth factor therapy
Procedure: Anti-vascular endothelial growth factor therapy
0.05 ml anti-VEGF, intravitreal, monthly
Other Names:
  • anti-VEGF
разрыв
group in which neuroepithelial detachment rupture was observed after anti-vascular endothelial growth factor therapy
Procedure: Anti-vascular endothelial growth factor therapy
0.05 ml anti-VEGF, intravitreal, monthly
Other Names:
  • anti-VEGF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediction algorithm
Time Frame: 1.09.2022
Neural network classifier
1.09.2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The S.N. Fyodorov Eye Microsurgery State Institution

Investigators

  • Study Director: Viktoria Myasnikova, D.Med.Sc., Deputy Director for Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

January 5, 2022

First Submitted That Met QC Criteria

January 12, 2022

First Posted (Actual)

January 26, 2022

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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