Potential Risk Factors and Predictive Model Construction of OBL During SMILE

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

4678 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2024-08-01

Brief Summary

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To explore the prediction of OBL by deep learning model in SMILE surgery

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Detailed Description

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The DL model was used to predict the OBL area during SMILE surgery by identifying the corneal full-view images before laser scanning. The DL model developed may assist surgeons to predict the possible OBL area of patients in advance, so as to adjust some surgical parameters and reduce the formation of OBL, which can avoid negative effects on surgeons' operation and patients' postoperative visual recovery, which has important practical significance.

Conditions

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Myopia Small-incision Lenticule Extraction (SMILE) Surgery

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Eyes with SMILE surgeries

Eyes with SMILE surgeries which were performed by three surgeons with different experiences.

Small incision lenticule extraction

Intervention Type PROCEDURE

Small incision lenticule extraction surgeries performed by two Refractive surgery experts (Refractive surgery expert 1: YYF, Associate Professor with 10 years of experience as a refractive surgeon; Refractive surgery expert 2: GF, Associate Professor with 5 years of experience as a refractive surgeon) and a Attending ophthalmologist (XJ, Attending ophthalmologist with 1 year of experience as a refractive surgeon).

Interventions

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Small incision lenticule extraction

Small incision lenticule extraction surgeries performed by two Refractive surgery experts (Refractive surgery expert 1: YYF, Associate Professor with 10 years of experience as a refractive surgeon; Refractive surgery expert 2: GF, Associate Professor with 5 years of experience as a refractive surgeon) and a Attending ophthalmologist (XJ, Attending ophthalmologist with 1 year of experience as a refractive surgeon).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* A condition in which the spherical equivalent refractive error of an eye is ≤ -0.50 D when ocular accommodation is relaxed;
* Age ≥18 years;
* Spherical equivalent (SE) ≥ -10.0D;
* Corrected distance visual acuity (CDVA) ≥ 16/20;
* Stable myopia for at least 2 years;
* No contact lenses wearing for at least 2 weeks

Exclusion Criteria

* The presence or history of eye conditions other than myopia and astigmatism, such as keratoconus or external eye injury;
* A history of eye surgery;
* The presence or history of systemic diseases.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes