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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05367154
Enrollment
3003
Registered
2022-05-10
Start date
2021-04-01
Completion date
2021-09-01
Last updated
2022-05-10

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

femtosecond laser, small-incision lenticule extraction (SMILE), unintended initial dissection of the posterior plane

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.

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

Sponsors

Yifeng Yu
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 number of patients with unintended initial dissection of the posterior plane in the SMILE surgeriesDay 0The number of patients with unintended initial dissection of the posterior plane were observed during the SMILE surgeries.

Secondary

MeasureTime frameDescription
The impact of spherical equivalent on the unintended initial dissection of the posterior plane (UIDPP) in SMILE surgeriesDay 0The spherical equivalent of eyes with UIDPP and eyes without UIDPP were analyzed, and statistical analysis was observed to investigate the impact of spherical equivalent on the UIDPP in SMILE surgeries.
The impact of peripheral corneal incision angle on the unintended initial dissection of the posterior plane (UIDPP) in SMILE surgeriesDay 0The peripheral corneal incision angle of eyes with UIDPP and eyes without UIDPP were analyzed, and statistical analysis was observed to investigate the impact of peripheral corneal incision angle on the UIDPP in SMILE surgeries.
The impact of peripheral lens thickness on the unintended initial dissectionDay 0The peripheral lens thickness of eyes with UIDPP and eyes without UIDPP were analyzed, and statistical analysis was observed to investigate the impact of peripheral corneal incision angle on the UIDPP in SMILE surgeries.
The impact of lens diameter on the unintended initial dissectionDay 0The lens diameter of eyes with UIDPP and eyes without UIDPP were analyzed, and statistical analysis was observed to investigate the impact of lens diameter on the UIDPP in SMILE surgeries.
The impact of central corneal thickness on the unintended initial dissectionDay 0The central corneal thickness of eyes with UIDPP and eyes without UIDPP were analyzed, and statistical analysis was observed to investigate the impact of central corneal thickness on the UIDPP in SMILE surgeries.

Countries

China

Outcome results

None listed

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