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Potential Risk Factors and Predictive Model Construction of OBL During SMILE

Predicting an Opaque Bubble Layer During Small-Incision Lenticule Extraction Surgery Based on Deep Learning

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06577012
Enrollment
4678
Registered
2024-08-29
Start date
2024-05-01
Completion date
2024-08-01
Last updated
2024-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia, Small-incision Lenticule Extraction (SMILE) Surgery

Keywords

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

Brief summary

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

Detailed 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.

Interventions

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).

Sponsors

Second Affiliated Hospital of Nanchang University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The area of patients with opaque bubble layer in the SMILE surgeriesDay 0The area of patients with opaque bubble layer were observed during the SMILE surgeries.

Secondary

MeasureTime frameDescription
Deep learning modelDay 0Predictive performance of deep learning model on the OBL in SMILE surgeries.
ResNet modelDay 0Predictive performance of ResNet model on the OBL in SMILE surgeries.
Vgg19 modelDay 0Predictive performance of Vgg model on the OBL in SMILE surgeries.
U-net modelDay 0Predictive performance of U-net model on the OBL in SMILE surgeries.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026