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OpenTrials
Completed

NCT Number: NCT05260775

Intelligent Evaluation and Supervision of Cataract Surgery

Research purpose: intelligent identification and evaluation of cataract surgery steps Research methods: A total of 9 items (such as gender, age, visual acuity, etc.) were extracted from the surgical videos of senile cataract patients and the clinical data recorded by the electronic medical record system. The machine learning algorithm 3D-CNN was applied to identify the 11 steps in cataract surgery and the pictures (blank pictures) without instrument manipulation on the eyeball during the operation. Six key cataract surgery steps were scored using deep learning algorithms (probability smoothing window and softmax). We employ precision, precision, recall, and F1-score to evaluate the model's performance for recognizing surgical steps. To evaluate the reliability of the model's scoring of surgical steps, we used a human-machine comparison method to calculate the agreement (kappa value) between machine and expert scores.

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Key information

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Who can participate

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

Inclusion criteria

-Videos of phacoemulsification and IOL implantation for senile cataracts will be included

Exclusion criteria

-The peak signal-to-noise ratio (PSNR) is utilized to assess whether a video was blurred. If the PSNR of a video was less than 20 decibels (dBs), the whole video was discarded.

Treatment and study plan

Evaluation test: cataract surgery steps

Other

The development datasets were used to train the deep learning model. The validation and test group were used to optimize hyperparameters

Primary outcomes

  1. Accuracy

    Time frame: baseline

    The investigators will calculate accuracy of deep learning system and compare this index between deep learning system and human doctors

Secondary outcomes

  1. kappa

    Time frame: baseline

    Cohen's kappa coefficient was calculated to assess the agreement between the grades given by human doctors and DeepSurgery

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 2, 2022
Registry last updated
Mar 2, 2022

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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