A Study of Artificial Intelligence Assisted Small Incision Lenticule Extraction (SMILE) for Surgical Design and Influencing Factors
- Conditions
- Myopic AstigmatismMyopia
- Interventions
- Procedure: AI-predicted Nomogram
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3000
- 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
- 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
- Arm && Interventions
Group Intervention Description AI-nomogram Group 1 AI-predicted Nomogram 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. AI-nomogram Group 2 AI-predicted Nomogram 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.
- 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