Clinical trial NCT05367154: Factor Analysis of Unintended Initial Dissection of the Posterior Plane
Official title: Identification of Factors Related to Unintended Initial Dissection of the Posterior Plane in Small Incision Lenticule Extraction Cases by Three Different Surgeons
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Small-incision Lenticule Extraction (SMILE) Surgery
Keywords: femtosecond laser
small-incision lenticule extraction (SMILE)
unintended initial dissection of the posterior plane
Lead sponsor: Second Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 3003
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from clinics in ophthalmic center of the second Affiliated Hospital of Nanchang University

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.

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.

Primary outcomes:
measure: The number of patients with unintended initial dissection of the posterior plane in the SMILE surgeries
timeFrame: Day 0
Secondary outcomes:
measure: The impact of spherical equivalent on the unintended initial dissection of the posterior plane (UIDPP) in SMILE surgeries
timeFrame: Day 0
measure: The impact of peripheral corneal incision angle on the unintended initial dissection of the posterior plane (UIDPP) in SMILE surgeries
timeFrame: Day 0
measure: The impact of peripheral lens thickness on the unintended initial dissection
timeFrame: Day 0
measure: The impact of lens diameter on the unintended initial dissection
timeFrame: Day 0
measure: The impact of central corneal thickness on the unintended initial dissection
timeFrame: Day 0
Other outcomes:
Locations:
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
Study officials:
References: