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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06229301

Enrollment

3000

Registered

2024-01-29

Start date

2014-03-01

Completion date

2024-09-30

Last updated

2024-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia, Myopic Astigmatism

Keywords

Small-incision Lenticule Extraction, Artificial Intelligence, Nomogram, Refractive Surgery, Myopia Correction

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.

Interventions

PROCEDUREAI-predicted Nomogram

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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

Countries

China

Contacts

Primary ContactYan Wang

wangyan7143@vip.sina.com+82227313336

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026