Skip to main content
OpenTrials
Completed

NCT Number: NCT05367154

Factor Analysis of Unintended Initial Dissection of the Posterior Plane

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. The number of patients with unintended initial dissection of the posterior plane in the SMILE surgeries

    Time frame: Day 0

    The number of patients with unintended initial dissection of the posterior plane were observed during the SMILE surgeries.

Secondary outcomes

  1. The impact of spherical equivalent on the unintended initial dissection of the posterior plane (UIDPP) in SMILE surgeries

    Time frame: Day 0

    The 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.

  2. The impact of peripheral corneal incision angle on the unintended initial dissection of the posterior plane (UIDPP) in SMILE surgeries

    Time frame: Day 0

    The 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.

  3. The impact of peripheral lens thickness on the unintended initial dissection

    Time frame: Day 0

    The 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.

  4. The impact of lens diameter on the unintended initial dissection

    Time frame: Day 0

    The 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.

  5. The impact of central corneal thickness on the unintended initial dissection

    Time frame: Day 0

    The 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.

Sponsors and collaborators

Lead sponsor

Yifeng Yu

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 10, 2022
Registry last updated
May 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.