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

Tianjin Eye Hospital3,000 enrolled

Overview

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

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

3,000

Conditions

Myopia Myopic Astigmatism

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Diopter

Spherical Diopter, cylindrical diopters and axis by Manifest Refraction Test

Time frame: 3 months after small incision lenticule extraction

Uncorrected Distance Visual Acuity (UDVA)

Time frame: 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

Secondary Outcomes

Corvis ST Test Result

Using OCULUS Corvis ST Test to obtain biomechanical parameters describing the biomechanical properties of the cornea

Time frame: Before small incision lenticule extraction and 3 months after small incision lenticule extraction

Aberration

Aberration measured by itrace

Time frame: 3 months after small incision lenticule extraction

Corneal Tomogram

Acquisition of corneal tomograms with the OCULUS Pentacam

Time frame: Before small incision lenticule extraction and 3 months after small incision lenticule extraction

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts