Potential Risk Factors and Predictive Model Construction of OBL During SMILE

NCT06577012 | Completed DMC

• 1 other identifier: 2024086
• Study Type: observational
• Target: 4,678
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myopia; Small-incision Lenticule Extraction (SMILE) Surgery

Keywords

small-incision lenticule extraction (SMILE); artificial intelligence; opaque bubble layer

Outcome Measures

Primary Outcomes (1)

• The area of patients with opaque bubble layer in the SMILE surgeries

  The area of patients with opaque bubble layer were observed during the SMILE surgeries.

  Day 0

Secondary Outcomes (4)

• Deep learning model

  Day 0

• ResNet model

  Day 0

• Vgg19 model

  Day 0

• U-net model

  Day 0

Study Arms (1)

Eyes with SMILE surgeries

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

Procedure: Small incision lenticule extraction

Interventions

Small incision lenticule extraction 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).

Eyes with SMILE surgeries

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients from clinics in ophthalmic center of the second Affiliated Hospital of Nanchang University

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead

Study Sites (1)

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

Location

MeSH Terms

Conditions

Myopia; Smiling

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Facial Expression; Nonverbal Communication; Communication; Behavior

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief physician of Ophthalmology center of the Second Affiliated Hospital of Nanchang University

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 29, 2024
• Study Start: May 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)