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

NCT06229301 | Unknown

• 1 other identifier: KY-2023076
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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

Conditions

Myopia; Myopic Astigmatism

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Diopter

  Spherical Diopter, cylindrical diopters and axis by Manifest Refraction Test

  3 months after small incision lenticule extraction

• 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 Outcomes (3)

• Corvis ST Test Result

  Before small incision lenticule extraction and 3 months after small incision lenticule extraction

• Aberration

  3 months after small incision lenticule extraction

• Corneal Tomogram

  Before small incision lenticule extraction and 3 months after small incision lenticule extraction

Study Arms (5)

Experienced-nomogram Group

Patients who underwent Small incision lenticule extraction (SMILE) from March 2014 to October 2018 in Refractive Surgery Center of Tianjin Eye Hospital and had at least three months of postoperative follow-up were included in this group. The Nomogram were based on experience of the surgeon.

AI-nomogram Group 1

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.

Procedure: AI-predicted Nomogram

AI-nomogram Group 2

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.

Procedure: AI-predicted Nomogram

Good Surgical Effect and Changes of Biological Parameters

-0.50D \< spherical equivalent (SE) \< 0.50D

Poor Surgical Effect and Changes of Biological Parameters

spherical equivalent (SE) \<-0.50D or \>0.50D

Interventions

AI-predicted Nomogram PROCEDURE

AI-nomogram Group 1; AI-nomogram Group 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Eye Hospital: lead
• Beihang University: collaborator

Study Sites (1)

Tianjin Eye Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Conditions

Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Yan Wang

  Tiajin Eye Hospital

  STUDY CHAIR

Central Study Contacts

Yan Wang

CONTACT

+82227313336; wangyan7143@vip.sina.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2023
• First Posted: January 29, 2024
• Study Start: March 1, 2014
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: January 29, 2024

Record last verified: 2024-01

Locations

CN (1)