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Completed

NCT Number: NCT04828187

Development and Validation of Deep Neural Networks for Blinking Identification and Classification

Primary objective of this study is the development and validation of a system of deep neural networks which automatically detects and classifies blinks as "complete" or "incomplete" in image sequences.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupoli, Evros, Greece

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About this study

This method is based on iris and sclera segmentation in both eyes from the acquired images, using state of the art deep learning encoder-decoder neural architectures (DLED). The sequence of the segmented frames is post-processed to calculate the distance between the eyelids of each eye (palpebral fissure) and the corresponding iris diameter. Theses quantities are temporally filtered and their fraction is subject to adaptive thresholding to identify blinks and determine their type, independently for each eye. The two DLEDs were trained with manually segmented images and the post-process was parameterized using a 4-minute video. After DLED training, the proposed system was tested on 8 different subjects, each one with a 4-10-minute video. Several metrics of blink detection and classification accuracy were calculated against the ground truth, which was generated by 3 independent experts, whose conflicts were resolved by a senior expert. Two independent blink identifications are assumed to be in agreement, if and only if there is sufficient temporal overlapping and the type of blink is the same between the DLED system and the ground truth.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Uncorrected Distance Visual Acuity above 6/12

Exclusion criteria

  • corneal opacities
  • age-related macular degeneration
  • diagnosis of psychiatric diseases
  • former eyelid surgery

Treatment and study plan

Comparison of the proposed artificial network with the ground truth

Diagnostic Test

Both eyes will be included for each study participant. Participants watched a 4-10-minute video in standard mesopic environmental lighting conditions at 3.5m viewing distance. Simultaneously, all blinking moves will be recorded through a web infrared camera.

The proposed system was tested on the 8 different subjects. Several metrics of blink detection and classification accuracy were calculated against the ground truth, which was generated by 3 independent experts, whose conflicts were resolved by a senior expert. Two independent blink identifications are assumed to be in agreement, if and only if there is sufficient temporal overlapping and the type of blink is the same between the DLED system and the ground truth.

Primary outcomes

  1. Identification of complete and incomplete blinks

    Time frame: up to 1 week

    Complete and incomplete blinks are defined by the "length of palpebral fissure-to-iris diameter" ratio

  2. First frame of each blink

    Time frame: up to 1 week

    The frame in which the upper eyelid starts to move down and cover the cornea

  3. Last frame of each blink

    Time frame: up to 1 week

    The frame in which eyelids open fully after a blink

Secondary outcomes

  1. Length of palpebral fissure of both eyes

    Time frame: up to 1 week

    The distance between the upper eyelid margin and the lower eyelid margin (ie. the vertical dimension of the palpebral fissure),

  2. Iris diameter of both eyes

    Time frame: up to 1 week

    The horizontal diameter of the iris (ie. the horizontal white-to white distance)

Sponsors and collaborators

Lead sponsor

Democritus University of Thrace

Other

Collaborators

  • University of Thessaly

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 1, 2021
Registry last updated
Jan 4, 2023

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

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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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