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Recruiting NCT06806085

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Small-incision Lenticule Extraction (SMILE) Surgery, Corneal Higher-order Wavefront Aberrations, Residual Lenticule. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Δ Higher-order Aberration [Time frame: Day 90]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

China · 1 center
  • The Second Affiliated Hospital of Nanchang University — Nanchang

Identifiers

NCT: NCT06806085 · [2024] NO.(138)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗