Factor Analysis of Unintended Initial Dissection of the Posterior Plane

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05367154
• Other study ID #: [2021] No. (031)
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: September 1, 2021

Study information

• Verified date: May 2022
• Source: Second Affiliated Hospital of Nanchang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3003
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia
• Surgical Wound

Intervention

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).

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
Yifeng Yu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients with unintended initial dissection of the posterior plane in the SMILE surgeries	The number of patients with unintended initial dissection of the posterior plane were observed during the SMILE surgeries.	Day 0
Secondary	The impact of spherical equivalent on the unintended initial dissection of the posterior plane (UIDPP) in SMILE surgeries	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.	Day 0
Secondary	The impact of peripheral corneal incision angle on the unintended initial dissection of the posterior plane (UIDPP) in SMILE surgeries	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.	Day 0
Secondary	The impact of peripheral lens thickness on the unintended initial dissection	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.	Day 0
Secondary	The impact of lens diameter on the unintended initial dissection	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.	Day 0
Secondary	The impact of central corneal thickness on the unintended initial dissection	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.	Day 0