Clinical trial NCT06806085: Analysis of Influencing Factors of High-Order Aberrations of SMILE with Lenticule Retained
Official title: Analysis of Influencing Factors of High-Order Aberrations of Small Incision Lenticule Extraction with Lenticule Retained
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Small-incision Lenticule Extraction (SMILE) Surgery
Corneal Higher-order Wavefront Aberrations
Residual Lenticule
Keywords: Residual Lenticule
Corneal Higher-order Wavefront Aberrations
Small-incision Lenticule Extraction
Lead sponsor: Second Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Each subject must have complete surgical video recordings and medical records.

Brief summary: Analysis of Influencing Factors of High-Order Aberrations of SMILE with Lenticule Retained

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Δ Higher-order Aberration
timeFrame: Day 90
Secondary outcomes:
Other outcomes:
Locations:
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
Study officials:
References: