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Potential Risk Factors and Predictive Model Construction of OBL During SMILE

N

Nanchang University

Status

Completed

Conditions

Myopia
Small-incision Lenticule Extraction (SMILE) Surgery

Treatments

Procedure: Small incision lenticule extraction

Study type

Observational

Funder types

Other

Identifiers

NCT06577012
2024086

Details and patient eligibility

About

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

Full description

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.

Enrollment

4,678 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

4,678 participants in 1 patient group

Eyes with SMILE surgeries
Description:
Eyes with SMILE surgeries which were performed by three surgeons with different experiences.
Treatment:
Procedure: Small incision lenticule extraction

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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