Factor Analysis of Unintended Initial Dissection of the Posterior Plane

NCT ID: NCT05367154

Last Updated: 2022-05-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3003 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2021-09-01

Brief 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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

Eyes with SMILE surgeries

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

Small incision lenticule extraction

Intervention Type: 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 (WNY, Attending ophthalmologist with 1 year of experience as a refractive surgeon).

Interventions

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).

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yifeng Yu

OTHER

Sponsor Role: lead

Responsible Party

Yifeng Yu

Deputy chief physician of Ophthalmology center of the Second Affiliated Hospital of Nanchang University

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Countries

China

Other Identifiers

[2021] No. (031)

Identifier Type: -

Identifier Source: org_study_id