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NCT Number: NCT06204926

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

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

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

The primary cause of global visual impairment currently is refractive error, and Small Incision Lenticule Extraction (SMILE) using femtosecond laser for corneal stromal lenticule extraction can alter the refractive power. However, complications such as opaque bubble layer (OBL), negative pressure detachment, and black spots may arise during the SMILE laser scanning process due to individual differences in corneal characteristics, significantly affecting the normal course of surgery and postoperative recovery. Experienced docters can often predict intraoperative complications based on scan images, patient cooperation, and other factors, but the learning curve is relatively long. At present, artificial intelligence has achieved the accuracy comparable to human physicians in the interpretation of medical imaging of many different diseases.Previously, we have trained a deep convolutional neural network for predicting intraoperative complications in SMILE procedures. The current multi-center study is designed to evaluate the efficacy of the convolutional neural network based algorithm in predicting intraoperative complications and to assess its utility in the real world.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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;
  • Stable myopia for at least 2 years;
  • No contact lenses wearing for at least 2 weeks.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. AUROC of convolutional neural network in predicting OBL area

    Time frame: Day 0

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

  2. AUROC of convolutional neural network in predicting progressive suction loss

    Time frame: Day 0

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

  3. AUROC of convolutional neural network in predicting effective optical zone

    Time frame: Day 7

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

  4. AUROC of convolutional neural network in predicting postoperative refractive error

    Time frame: Day 7

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

  5. AUROC of convolutional neural network in predicting postoperative central corneal thickness

    Time frame: Day 7

    The area under the receiver operating characteristic of convolutional neural network in predicting central corneal thickness after the SMILE surgeries

Secondary outcomes

  1. Sensitivity and specificity of convolutional neural network in predicting OBL area

    Time frame: Day 0

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

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

    Time frame: Day 0

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

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

    Time frame: Day 7, Day 30, Day 90

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

Study contacts

Contact information is provided by the study sponsor or research team.

Fu Gui, docter

CONTACT

[email protected]

13879101919 ext. +86

Jian Xiong, docter

CONTACT

[email protected]

18170906556 ext. +86

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Nanchang University

Other

Collaborators

  • Hangzhou Huaxia Eye Hospital
  • Nanchang Bright Eye Hospital

Registry information

Official study title

Diagnostic Efficacy of Convolutional Neural Network Based Algorithm in Predicting Intraoperative Complications and Postoperative Outcomes in Small Incision Lenticule Extraction

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jan 12, 2024
Registry last updated
Apr 24, 2026

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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