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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06229301
• Other study ID #: KY-2023076
• Status: Recruiting
• Start date: March 1, 2014
• Est. completion date: September 30, 2024

Study information

• Verified date: January 2024
• Source: Tianjin Eye Hospital
• Contact: Yan Wang
• Phone: +82227313336
• Email: wangyan7143[@]vip.sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Astigmatism
• Myopia
• Myopic Astigmatism

Intervention

Procedure:
• AI-predicted Nomogram

Locations

Country	Name	City	State
China	Tianjin Eye Hospital	Tianjin	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Tianjin Eye Hospital	Beihang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diopter	Spherical Diopter, cylindrical diopters and axis by Manifest Refraction Test	3 months after small incision lenticule extraction
Primary	Uncorrected Distance Visual Acuity (UDVA)		3 months after small incision lenticule extraction
Primary	Corrected Distance Visual Acuity (CDVA)		Before small incision lenticule extraction 3 months after small incision lenticule extraction
Secondary	Corvis ST Test Result	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
Secondary	Aberration	Aberration measured by itrace	3 months after small incision lenticule extraction
Secondary	Corneal Tomogram	Acquisition of corneal tomograms with the OCULUS Pentacam	Before small incision lenticule extraction and 3 months after small incision lenticule extraction