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NCT Number: NCT06806085

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

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

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years, gender unrestricted;
  • 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;
  • The patient voluntarily participates in this study, signs the informed consent form, and agrees to follow up according to the study plan;
  • Predicted postoperative residual corneal stromal thickness ≥ 280 micrometers.

Exclusion criteria

  • Subclinical keratoconus, keratoconus, moderate to severe corneal opacities or scars, and other ocular conditions;
  • Diabetes, keloid-prone constitution, autoimmune and connective tissue diseases, etc.;
  • Severe mental disorders such as generalized anxiety disorder, panic disorder, depression, schizophrenia, and bipolar disorder; inability to cooperate with physicians;
  • Refusal to participate in the study.

Treatment and study plan

Primary outcomes

  1. Δ Higher-order Aberration

    Time frame: Day 90

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

Study contacts

Contact information is provided by the study sponsor or research team.

Fu Gui, docter

CONTACT

[email protected]

+861387910191

Jian Xiong, doctor

CONTACT

[email protected]

+8618170906556

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Nanchang University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 3, 2025
Registry last updated
Apr 22, 2026

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.

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