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Recruiting NCT06806085

Analysis of Influencing Factors of High-Order Aberrations of SMILE With Lenticule Retained

Conditions: Small-incision Lenticule Extraction (SMILE) Surgery Corneal Higher-order Wavefront Aberrations Residual Lenticule

Sponsor: Second Affiliated Hospital of Nanchang University

trial.available_in: БГ
Overview
Analysis of Influencing Factors of High-Order Aberrations of SMILE with Lenticule Retained
Description
Wavefront analysis and other objective methods are the mainstream approaches for assessing visual quality after refractive surgery, with high-order aberrations being the main observation indicators. Some studies have explored the correlation between various complications after SMILE surgery and high-order aberrations. However, research on lenticule retained after surgery has mainly focused on clinical management and case reports of overt lenticule retained, while there is a lack of high-quality observational studies on the population with covert lenticule retained (periphery residual lenticule) to serve as evidence. This often puts clinicians in a dilemma of whether to perform another surgery to remove the remnants. In summary, although research on lenticule retained after SMILE surgery is gradually increasing, systematic studies on their relationship with higher-order aberrations are still insufficient. This study aims to fill the gap in existing research by comparing and analyzing high-order aberrations between patients with and without periphery residual lenticule, providing a more comprehensive assessment of postoperative visual quality. This will offer important theoretical basis and practical guidance for improving SMILE surgical techniques and optimizing postoperative management.
Who can participate
Inclusion Criteria: 1. Age ≥ 18 years, gender unrestricted; 2. Equivalent spherical refraction ≤ -10.0D, corrected distance visual acuity ≥ 1.0, myopia stable for ≥ 2 years, and no contact lens wear for at least 2 weeks; 3. The patient voluntarily participates in this study, signs the informed consent form, and agrees to follow up according to the study plan; 4. Predicted postoperative residual corneal stromal thickness ≥ 280 micrometers. Exclusion Criteria: 1. Subclinical keratoconus, keratoconus, moderate to severe corneal opacities or scars, and other ocular conditions; 2. Diabetes, keloid-prone constitution, autoimmune and connective tissue diseases, etc.; 3. Severe mental disorders such as generalized anxiety disorder, panic disorder, depression, schizophrenia, and bipolar disorder; inability to cooperate with physicians; 4. Refusal to participate in the study.
Locations 1
China (1)
The Second Affiliated Hospital of Nanchang University
Nanchang , Jiangxi
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
45 Years
Healthy volunteers
No
Start date
31.10.2024
Completion date
31.10.2026
Registry ID
NCT06806085
Source
clinicaltrials.gov
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