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

April 21, 2026 updated by: Jian Xiong, Second Affiliated Hospital of Nanchang University

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

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

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangxi
      • Nanchang, Jiangxi, China, 330000
        • Recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Each subject must have complete surgical video recordings and medical records.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
lenticule retained group
Non-lenticule retained group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Nanchang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2024

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

January 26, 2025

First Submitted That Met QC Criteria

January 30, 2025

First Posted (Actual)

February 3, 2025

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • [2024] NO.(138)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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