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

Recruiting

• Conditions: Myopic Astigmatism; Myopia

• Registration Number: NCT06229301
• Lead Sponsor: Tianjin Eye Hospital

Brief Summary

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

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 Timeline

• Study Start: 2014-03-01
• Study First Submitted: 2023-12-16
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-19
• Last Update Submitted: 2024-01-19
• Study First Posted: 2024-01-29
• Last Update Posted: 2024-01-29
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Aberration	3 months after small incision lenticule extraction	Aberration measured by itrace
Corneal Tomogram	Before small incision lenticule extraction and 3 months after small incision lenticule extraction	Acquisition of corneal tomograms with the OCULUS Pentacam
Corvis ST Test Result	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

Trial Locations

Locations (1)

Tianjin Eye Hospital; 🇨🇳 Tianjin, Tianjin, China