Potential Risk Factors and Predictive Model Construction of OBL During SMILE

August 27, 2024 updated by: Yifeng Yu, Second Affiliated Hospital of Nanchang University

Predicting an Opaque Bubble Layer During Small-Incision Lenticule Extraction Surgery Based on Deep Learning

To explore the prediction of OBL by deep learning model in SMILE surgery

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The DL model was used to predict the OBL area during SMILE surgery by identifying the corneal full-view images before laser scanning. The DL model developed may assist surgeons to predict the possible OBL area of patients in advance, so as to adjust some surgical parameters and reduce the formation of OBL, which can avoid negative effects on surgeons' operation and patients' postoperative visual recovery, which has important practical significance.

Study Type

Observational

Enrollment (Actual)

4678

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangxi
      • Nanchang, Jiangxi, China, 330000
        • The Second Affiliated Hospital of Nanchang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients from clinics in ophthalmic center of the second Affiliated Hospital of Nanchang University

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Eyes with SMILE surgeries
Eyes with SMILE surgeries which were performed by three surgeons with different experiences.
Procedure: Small incision lenticule extraction
Small incision lenticule extraction surgeries performed by two Refractive surgery experts (Refractive surgery expert 1: YYF, Associate Professor with 10 years of experience as a refractive surgeon; Refractive surgery expert 2: GF, Associate Professor with 5 years of experience as a refractive surgeon) and a Attending ophthalmologist (XJ, Attending ophthalmologist with 1 year of experience as a refractive surgeon).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The area of patients with opaque bubble layer in the SMILE surgeries
Time Frame: Day 0
The area of patients with opaque bubble layer were observed during the SMILE surgeries.
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deep learning model
Time Frame: Day 0
Predictive performance of deep learning model on the OBL in SMILE surgeries.
Day 0
ResNet model
Time Frame: Day 0
Predictive performance of ResNet model on the OBL in SMILE surgeries.
Day 0
Vgg19 model
Time Frame: Day 0
Predictive performance of Vgg model on the OBL in SMILE surgeries.
Day 0
U-net model
Time Frame: Day 0
Predictive performance of U-net model on the OBL in SMILE surgeries.
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Nanchang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

August 26, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 29, 2024

Study Record Updates

Last Update Posted (Actual)

August 29, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024086

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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