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

Analysis of Influencing Factors of High-Order Aberrations of Small Incision Lenticule Extraction With Lenticule Retained

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06806085
Enrollment
33
Registered
2025-02-03
Start date
2024-10-31
Completion date
2026-10-31
Last updated
2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Residual Lenticule, Corneal Higher-order Wavefront Aberrations, Small-incision Lenticule Extraction

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.

Interventions

None listed

Sponsors

Second Affiliated Hospital of Nanchang University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Δ Higher-order AberrationDay 90Preoperative and postoperative Higher-order aberration difference obtained from wavefront aberrations map of corneal topography in Pentacam measurement.

Countries

China

Contacts

CONTACTJian Xiong, doctor
894040417@qq.com+8618170906556
CONTACTFu Gui, docter
564436578@qq.com+861387910191

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 23, 2026