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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-31

Study Completion Date

2025-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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lenticule retained group

No interventions assigned to this group

Non-lenticule retained group

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No