A Study of Artificial Intelligence Assisted Small Incision Lenticule Extraction (SMILE) for Surgical Design and Influencing Factors

January 19, 2024 updated by: Tianjin Eye Hospital

Artificial Intelligence Assisted Small Incision Lenticule Extraction (SMILE) for Surgical Design and Nomogram Predicting and Related Influencing Factors to Surgical Outcomes

The goal of this observational study is to learn about the difference of refractive outcomes between Artificial Intelligence and experienced surgeon predicting Nomogram assist SMILE surgical design and the influenced factors of refractive outcomes in patients who underwent Small Incision Lenticule Extraction(SMILE) at the Refractive Surgery Center of Tianjin Eye Hospital. The main questions it aims to answer are:

  • Compare the difference of refractive outcomes between Artificial Intelligence and experienced surgeon predicting Nomogram assist SMILE surgical design
  • Analysis the influenced factors of refractive outcomes

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this ambispective observation study, to compare the difference of refractive outcomes between Artificial Intelligence and experienced surgeon predicting Nomogram assist SMILE surgical design and Analysis the influenced factors of refractive outcomes, patients have been continuously recruited and the data can then be used for further case-control and cohort studies.

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China
        • Recruiting
        • Tianjin Eye Hospital
        • Contact:

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

No

Sampling Method

Non-Probability Sample

Study Population

This ambispective study included 3246 eyes of 1643 patients with myopia or myopic astigmatism until September 2023. All of patients were accepted the SMILE surgery from May 2014 to June 2023 in Tianjin Eye Hospital. Additional participants will be recruited until September 30, 2024.

Baseline and postoperative measurements included uncorrected distance visual acuity (UDVA), CDVA, cycloplegic and manifest refraction, slit-lamp and fundus examination, corneal topography and intraocular pressure. Postoperative examinations were scheduled at 1 day, 1 week, 1 month and 3 months. Before surgery, all patients had received 0.5% levofloxacin eyedrops 4 times daily for 3 days.

Description

Inclusion Criteria:

  • Age of 18 years and older
  • Stable refraction over the past 2 years
  • Corrected distance visual acuity (CDVA) of 20/25 or better
  • Soft contact lens discontinued 2 weeks or longer
  • Rigid contact lens discontinued 4 weeks or longer

Exclusion Criteria:

  • Abnormal corneal topographic features
  • Severe dry eye
  • Active keratitis
  • Corneal scars
  • Keratoconus or suspected keratoconus,
  • Glaucoma
  • Retina diseases
  • History of intraocular or corneal surgery
  • Pregnant or lactating women, required chronic systemic corticosteroids or immunocompromised subjects were also excluded from this study

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
Experienced-nomogram Group
Patients who underwent Small incision lenticule extraction (SMILE) from March 2014 to October 2018 in Refractive Surgery Center of Tianjin Eye Hospital and had at least three months of postoperative follow-up were included in this group. The Nomogram were based on experience of the surgeon.
AI-nomogram Group 1
Patients who underwent Small incision lenticule extraction (SMILE) from November 2018 to May 2021 in Refractive Surgery Center of Tianjin Eye Hospital and had at least three months of postoperative follow-up were included in this group. AI-predicted nomogram was obtained and used on patients who underwent surgery.
Procedure: AI-predicted Nomogram
AI-nomogram Group 2
Patients who underwent Small incision lenticule extraction (SMILE) from January 2023 in Refractive Surgery Center of Tianjin Eye Hospital and had at least three months of postoperative follow-up were included in this group. The datasets used to train AI(Artificial Intelligence) models have been continuously updated for better accuracy since 2018, the newest AI-predicted nomogram was obtained and used on patients who underwent surgery.
Procedure: AI-predicted Nomogram
Good Surgical Effect and Changes of Biological Parameters
-0.50D < spherical equivalent (SE) < 0.50D
Poor Surgical Effect and Changes of Biological Parameters
spherical equivalent (SE) <-0.50D or >0.50D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diopter
Time Frame: 3 months after small incision lenticule extraction
Spherical Diopter, cylindrical diopters and axis by Manifest Refraction Test
3 months after small incision lenticule extraction
Uncorrected Distance Visual Acuity (UDVA)
Time Frame: 3 months after small incision lenticule extraction
3 months after small incision lenticule extraction
Corrected Distance Visual Acuity (CDVA)
Time Frame: Before small incision lenticule extraction 3 months after small incision lenticule extraction
Before small incision lenticule extraction 3 months after small incision lenticule extraction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corvis ST Test Result
Time Frame: Before small incision lenticule extraction and 3 months after small incision lenticule extraction
Using OCULUS Corvis ST Test to obtain biomechanical parameters describing the biomechanical properties of the cornea
Before small incision lenticule extraction and 3 months after small incision lenticule extraction
Aberration
Time Frame: 3 months after small incision lenticule extraction
Aberration measured by itrace
3 months after small incision lenticule extraction
Corneal Tomogram
Time Frame: Before small incision lenticule extraction and 3 months after small incision lenticule extraction
Acquisition of corneal tomograms with the OCULUS Pentacam
Before small incision lenticule extraction and 3 months after small incision lenticule extraction

Collaborators and Investigators

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

Sponsor

Tianjin Eye Hospital

Collaborators

Beihang University

Investigators

  • Study Chair: Yan Wang, Tiajin Eye Hospital

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)

March 1, 2014

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

December 16, 2023

First Submitted That Met QC Criteria

January 19, 2024

First Posted (Estimated)

January 29, 2024

Study Record Updates

Last Update Posted (Estimated)

January 29, 2024

Last Update Submitted That Met QC Criteria

January 19, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY-2023076

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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