NCT05367154

Factor Analysis of Unintended Initial Dissection of the Posterior Plane

Identification of Factors Related to Unintended Initial Dissection of the Posterior Plane in Small Incision Lenticule Extraction Cases by Three Different Surgeons

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,003 (actual)
• Sponsor: Yifeng Yu · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To explore the potential factors for unintended initial dissection of the posterior plane in a large sample retrospective analysis and surgeons of different levels.

Detailed description

Myopia is the most common eye disease in the world. Femtosecond laser small incision lens extraction (SMILE) has increasingly become the first choice in refractive surgery due to its greater biomechanical stability, less impact on the tear film and other advantages. However, because SMILE surgery is more challenging than flap-based corneal ablative surgery, young surgeons sometimes dissect the lenticule posterior plane first in clinical practice, which will make it more difficult to extract the lenticule or even cause the retained lenticule. The purpose of this study aims to explore the potential risk factors for unintended initial dissection of the posterior plane in large samples and surgeons of different surgical volumes and different surgical habits (different angles of peripheral corneal incision) in multiple scenarios.

Conditions

• Myopia
• Small-incision Lenticule Extraction (SMILE) Surgery

Interventions

Type	Name	Description
PROCEDURE	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 (WNY, Attending ophthalmologist with 1 year of experience as a refractive surgeon).

Timeline

• Start date: 2021-04-01
• Primary completion: 2021-09-01
• Completion: 2021-09-01
• First posted: 2022-05-10
• Last updated: 2022-05-10

Locations

1 site across 1 country: China