The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000, China
NCT Number: NCT05367154
To explore the potential factors for unintended initial dissection of the posterior plane in a large sample retrospective analysis and surgeons of different levels.
Looking for future studies?
Notify Me18 year–45 year
All sexes
Observational
Nanchang, Jiangxi, 330000, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: Day 0
The number of patients with unintended initial dissection of the posterior plane were observed during the 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.
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.
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.
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.
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.
Yifeng Yu
Other
Identification of Factors Related to Unintended Initial Dissection of the Posterior Plane in Small Incision Lenticule Extraction Cases by Three Different Surgeons
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.
NCT06577012
Behavior, Communication
Nanchang, Jiangxi, China
View Trial DetailsNCT07087665
Eye Diseases, Myopia
Saint Louis Park, Minnesota, United States
View Trial DetailsNCT06700460
Eye Diseases, Myopia
Omaha, Nebraska, United States
View Trial DetailsNCT03334253
Eye Diseases, Myopia
Birmingham, Alabama, United States
View Trial Details