Analyzing factors affecting vision quality after SMILE surgery
Official title: Analysis of Influencing Factors of High-Order Aberrations of Small Incision Lenticule Extraction With Lenticule Retained
Run by Second Affiliated Hospital of Nanchang University · NCT06806085 · Data updated 2026-11-12
This study is trying to see how leftover tissue after SMILE eye surgery affects vision quality in patients.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | All |
| Enrollment | 33 (estimated) |
| Sponsor | Second Affiliated Hospital of Nanchang University Academic / other |
| Locations | 1 site (Nanchang, Jiangxi) |
| Status | Recruiting |
| Started | October 31, 2024 |
| Main results expected | October 31, 2026 |
| Study ends | October 31, 2026 |
| Registry record updated | April 22, 2026 |
| Trial ID | NCT06806085 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with stable myopia and specific corneal thickness criteria.
✕Probably not a fit
Patients with significant ocular conditions or severe mental disorders may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the relationship between high-order aberrations and the presence of residual lenticule after Small-incision Lenticule Extraction (SMILE) surgery. It aims to compare visual quality outcomes in patients with and without peripheral residual lenticule, addressing a gap in existing research. By utilizing wavefront analysis and other objective methods, the study seeks to provide insights that could guide clinicians in managing postoperative complications and improving surgical techniques. The findings may help in making informed decisions regarding the necessity of additional surgical interventions.
Why it matters
Potential benefit: If successful, this study could enhance postoperative visual quality for patients undergoing SMILE surgery.
How similar studies have gone: While there is increasing research on lenticule retention after SMILE, this study addresses a relatively novel aspect that has not been extensively explored.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China Recruiting
Study contacts
- Study coordinator: Jian Xiong, doctor
- Email: 894040417@qq.com
- Phone: +8618170906556
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.