A Study of Artificial Intelligence Assisted Small Incision Lenticule Extraction (SMILE) for Surgical Design and Influencing Factors
NCT ID: NCT06229301
Last Updated: 2024-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
3000 participants
OBSERVATIONAL
2014-03-01
2024-09-30
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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OTHER
OTHER
Study Groups
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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.
No interventions assigned to this group
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.
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.
AI-predicted Nomogram
Good Surgical Effect and Changes of Biological Parameters
-0.50D \< spherical equivalent (SE) \< 0.50D
No interventions assigned to this group
Poor Surgical Effect and Changes of Biological Parameters
spherical equivalent (SE) \<-0.50D or \>0.50D
No interventions assigned to this group
Interventions
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AI-predicted Nomogram
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
ALL
No
Sponsors
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Beihang University
OTHER
Tianjin Eye Hospital
OTHER
Responsible Party
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Principal Investigators
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Yan Wang
Role: STUDY_CHAIR
Tiajin Eye Hospital
Locations
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Tianjin Eye Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KY-2023076
Identifier Type: -
Identifier Source: org_study_id
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