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

Sponsor
The S.N. Fyodorov Eye Microsurgery State Institution (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05208931
Collaborator
(none)
300
1
10
30

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Anti-vascular endothelial growth factor therapy

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 Design

Study Type:
Observational
Actual Enrollment :
300 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
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.
Actual Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. Prediction algorithm [1.09.2022]

      Neural network classifier

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The S.N. Fyodorov Eye Microsurgery State Institution Krasnodar Russian Federation 350012

    Sponsors and Collaborators

    • The S.N. Fyodorov Eye Microsurgery State Institution

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Viktoria Myasnikova, Deputy Director for Research, The S.N. Fyodorov Eye Microsurgery State Institution
    ClinicalTrials.gov Identifier:
    NCT05208931
    Other Study ID Numbers:
    • 1
    First Posted:
    Jan 26, 2022
    Last Update Posted:
    Jan 26, 2022
    Last Verified:
    Jan 1, 2022
    Keywords provided by Viktoria Myasnikova, Deputy Director for Research, The S.N. Fyodorov Eye Microsurgery State Institution
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 26, 2022