Clinical trial NCT06229301: A Study of Artificial Intelligence Assisted Small Incision Lenticule Extraction (SMILE) for Surgical Design and Influencing Factors
Official title: Artificial Intelligence Assisted Small Incision Lenticule Extraction (SMILE) for Surgical Design and Nomogram Predicting and Related Influencing Factors to Surgical Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myopia
Myopic Astigmatism
Keywords: Small-incision Lenticule Extraction
Artificial Intelligence
Nomogram
Refractive Surgery
Myopia Correction
Lead sponsor: Tianjin Eye Hospital
Sponsor class: OTHER
Collaborators: name: Beihang University
First posted: 2024-01-29
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This ambispective study included 3246 eyes of 1643 patients with myopia or myopic astigmatism until September 2023. All of patients were accepted the SMILE surgery from May 2014 to June 2023 in Tianjin Eye Hospital. Additional participants will be recruited until September 30, 2024.

Baseline and postoperative measurements included uncorrected distance visual acuity (UDVA), CDVA, cycloplegic and manifest refraction, slit-lamp and fundus examination, corneal topography and intraocular pressure. Postoperative examinations were scheduled at 1 day, 1 week, 1 month and 3 months. Before surgery, all patients had received 0.5% levofloxacin eyedrops 4 times daily for 3 days.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diopter
timeFrame: 3 months after small incision lenticule extraction
measure: Uncorrected Distance Visual Acuity (UDVA)
timeFrame: 3 months after small incision lenticule extraction
measure: Corrected Distance Visual Acuity (CDVA)
timeFrame: Before small incision lenticule extraction 3 months after small incision lenticule extraction
Secondary outcomes:
measure: Corvis ST Test Result
timeFrame: Before small incision lenticule extraction and 3 months after small incision lenticule extraction
measure: Aberration
timeFrame: 3 months after small incision lenticule extraction
measure: Corneal Tomogram
timeFrame: Before small incision lenticule extraction and 3 months after small incision lenticule extraction
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Eye Hospital
state: Tianjin
Study officials:
affiliation: Tiajin Eye Hospital
name: Yan Wang
role: STUDY_CHAIR
References: