Actively Recruiting

Age: 18Years - 45Years
All Genders
ID06806085

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

Led by Second Affiliated Hospital of Nanchang University · Updated on 2026-04-22

33

Participants Needed

1

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

This research aims to analyze the factors influencing high-order aberrations following Small Incision Lenticule Extraction (SMILE) surgery, focusing on patients with lenticule retained. High-order aberrations are key indicators used to assess visual quality after refractive surgery. While previous studies have explored complications related to these aberrations, there is limited high-quality research on patients with covert residual lenticule, which complicates clinical decisions about additional surgery. The study compares high-order aberrations between patients with and without peripheral residual lenticule to provide a detailed evaluation of postoperative visual quality. It involves two groups: the lenticule retained group and the non-lenticule retained group. This observational study does not involve treatment interventions but collects data to understand the relationship between residual lenticule and visual outcomes. Participants will be followed up with assessments of higher-order aberrations at 90 days post-surgery. The study includes clinical evaluations and wavefront analysis to measure visual quality objectively. The findings aim to guide improvements in SMILE surgical techniques and postoperative care. The total participation involves initial assessment and follow-up visits as per the study plan.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 45Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Equivalent spherical refraction of -10.0 diopters or less
  • Corrected distance visual acuity of 1.0 or better
  • Stable myopia for at least 2 years
  • No contact lens wear for at least 2 weeks before the study
  • Voluntary participation with signed informed consent
  • Predicted postoperative residual corneal stromal thickness of 280 micrometers or more
Not Eligible

You will not qualify if you...

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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 90 days

Participants undergo eye examinations and wavefront analysis to assess high-order aberrations and determine lenticule retention status after SMILE surgery.

1 baseline visit and 1 follow-up visit

Long-term Monitoring

Duration - Up to 90 days

Participants are observed to compare visual quality and monitor high-order aberrations over time between those with and without periphery residual lenticule.

1 follow-up visit at Day 90

Trial Site Locations

Total: 1 location

1

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China, 330000

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Research Team

J

Jian Xiong, doctor

F

Fu Gui, docter

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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