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

T

Tianjin Eye Hospital

Status

Enrolling

Conditions

Myopia
Myopic Astigmatism

Treatments

Procedure: AI-predicted Nomogram

Study type

Observational

Funder types

Other

Identifiers

NCT06229301
KY-2023076

Details and patient eligibility

About

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

Full 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.

Enrollment

3,000 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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

Trial design

3,000 participants in 5 patient groups

Experienced-nomogram Group
Description:
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
Description:
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.
Treatment:
Procedure: AI-predicted Nomogram
AI-nomogram Group 2
Description:
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.
Treatment:
Procedure: AI-predicted Nomogram
Good Surgical Effect and Changes of Biological Parameters
Description:
-0.50D < spherical equivalent (SE) < 0.50D
Poor Surgical Effect and Changes of Biological Parameters
Description:
spherical equivalent (SE) <-0.50D or >0.50D

Trial contacts and locations

1

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Central trial contact

Yan Wang

Data sourced from clinicaltrials.gov

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