Diagnostic Efficacy of CNN in Predicting Intraoperative Complications and Postoperative Outcomes in SMILE

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-45
SponsorSecond Affiliated Hospital of Nanchang University

About this trial

To evaluate the diagnostic efficiency of the neural network in predicting complications of Small Incision Lenticule Extraction in a multi-center cross-sectional study.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

A condition in which the spherical equivalent refractive error of an eye is ≤-0.50 D when ocular accommodation is relaxed;

Age ≥18 years;

Spherical equivalent (SE) ≥-10.0D;

Corrected distance visual acuity (CDVA) ≥16/20;

Disqualifiers

The presence or history of eye conditions other than myopia and astigmatism, such as keratoconus or external eye injury;

A history of eye surgery;

The presence or history of systemic diseases.

Trial population

Patients from clinics in different eye centers across China. Each subject must with complete surgical video recording and medical records.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • AI diagnostic algorithm

    Diagnostic test

    The SMILE procedures collected would be assessed by the algorithm. The performance of the algorithm would be assessed, including accuracy, AUC, sensitivity and specificity.

Treatment groups

1,250 Participants
are divided into 1 treatment group
Group A: Eyes with SMILE surgeries1 intervention

Trial outcomes

Primary outcomes

1

AUROC of convolutional neural network in predicting OBL area

The area under the receiver operating characteristic of convolutional neural network in predicting opaque bubble layer area during the SMILE surgeries

Time frame
Day 0
2

AUROC of convolutional neural network in predicting progressive suction loss

The area under the receiver operating characteristic of convolutional neural network in predicting progressive suction loss during the SMILE surgeries

Time frame
Day 0
3

AUROC of convolutional neural network in predicting effective optical zone

The area under the receiver operating characteristic of convolutional neural network in predicting effective optical zone after the SMILE surgeries

Time frame
Day 7
4

AUROC of convolutional neural network in predicting postoperative refractive error

The area under the receiver operating characteristic of convolutional neural network in predicting refractive error after the SMILE surgeries

Time frame
Day 7

Secondary outcomes

1

Sensitivity and specificity of convolutional neural network in predicting OBL area

Sensitivity and specificity of convolutional neural network in predicting opaque bubble layer area during the SMILE surgeries

Time frame
Day 0
2

Sensitivity and specificity of convolutional neural network in predicting progressive suction loss

Sensitivity and specificity of convolutional neural network in predicting progressive suction loss during the SMILE surgeries

Time frame
Day 0
3

Sensitivity and specificity of convolutional neural network in predicting effective optical zone

ensitivity and specificity of convolutional neural network in predicting effective optical zone after the SMILE surgeries

Time frame
Day 7, Day 30, Day 90

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital of Nanchang University

Lead sponsor

Hangzhou Huaxia Eye Hospital

Collaborator

Nanchang Bright Eye Hospital

Collaborator