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Completed

NCT Number: NCT05208931

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

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.

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Key information

Conditions

Neovascular Age-related Macular Degeneration

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The S.N. Fyodorov Eye Microsurgery State Institution

Krasnodar, 350012, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anti-vascular endothelial growth factor therapy

Procedure

0.05 ml anti-VEGF, intravitreal, monthly

Other names: anti-VEGF

Primary outcomes

  1. Prediction algorithm

    Time frame: 1.09.2022

    Neural network classifier

Sponsors and collaborators

Lead sponsor

The S.N. Fyodorov Eye Microsurgery State Institution

Other Gov

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 26, 2022
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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