NCT06806085

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
6mo left

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Oct 2024Oct 2026

Study Start

First participant enrolled

October 31, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

April 22, 2026

Status Verified

October 1, 2025

Enrollment Period

2 years

First QC Date

January 26, 2025

Last Update Submit

April 21, 2026

Conditions

Small-incision Lenticule Extraction (SMILE) SurgeryCorneal Higher-order Wavefront AberrationsResidual Lenticule

Keywords

Residual LenticuleCorneal Higher-order Wavefront AberrationsSmall-incision Lenticule Extraction

Outcome Measures

Primary Outcomes (1)

  • Δ Higher-order Aberration

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

    Day 90

Study Arms (2)

lenticule retained group

Non-lenticule retained group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

RECRUITING

MeSH Terms

Conditions

Smiling

Condition Hierarchy (Ancestors)

Facial ExpressionNonverbal CommunicationCommunicationBehavior

Central Study Contacts

Jian Xiong, doctor

CONTACT

+8618170906556894040417@qq.com

Fu Gui, docter

CONTACT

+861387910191564436578@qq.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate research fellow; Attending physician

Study Record Dates

First Submitted

January 26, 2025

First Posted

February 3, 2025

Study Start

October 31, 2024

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

April 22, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)