Status:
RECRUITING
Diagnostic Efficacy of CNN in Predicting Intraoperative Complications and Postoperative Outcomes in SMILE
Lead Sponsor:
Second Affiliated Hospital of Nanchang University
Collaborating Sponsors:
Hangzhou Huaxia Eye Hospital
Nanchang Bright Eye Hospital
Conditions:
Deep Convolutional Neural Network
Small-incision Lenticule Extraction (SMILE) Surgery
Eligibility:
All Genders
18-45 years
Brief Summary
To evaluate the diagnostic efficiency of the neural network in predicting complications of Small Incision Lenticule Extraction in a multi-center cross-sectional study.
Detailed Description
The primary cause of global visual impairment currently is refractive error, and Small Incision Lenticule Extraction (SMILE) using femtosecond laser for corneal stromal lenticule extraction can alter ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
1250 Patients enrolled
Trial Details
Trial ID
NCT06204926
Start Date
June 15 2021
End Date
December 1 2025
Last Update
August 29 2025
Active Locations (1)
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1
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330000