Analyzing factors affecting vision quality after SMILE surgery
Analysis of Influencing Factors of High-Order Aberrations of Small Incision Lenticule Extraction With Lenticule Retained
This study is trying to see how leftover tissue after SMILE eye surgery affects vision quality in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 33 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Nanchang University Academic / other |
| Locations | 1 site (Nanchang, Jiangxi) |
| Trial ID | NCT06806085 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with stable myopia and specific corneal thickness criteria.
Not a fit: Patients with significant ocular conditions or severe mental disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance postoperative visual quality for patients undergoing SMILE surgery.
How similar studies have performed: While there is increasing research on lenticule retention after SMILE, this study addresses a relatively novel aspect that has not been extensively explored.
Eligibility criteria
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 this trial is running
Nanchang, Jiangxi
- The Second Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
Study contacts
- Study coordinator: Jian Xiong, doctor
- Email: 894040417@qq.com
- Phone: +8618170906556
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.