Actively Recruiting
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
On this page
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
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Actively Recruiting
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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