Understanding factors affecting suction loss in corneal refractive surgery
Analysis of Factors Associated With Threatened Aspiration in Patients Undergoing Small-incision Lenticule Extraction (SMILE) : Prospective Study
This study is trying to find out what factors make some patients lose suction during corneal refractive surgery, so doctors can better understand who might be at risk and improve surgery results.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Nanchang University Academic / other |
| Locations | 1 site (Nanchang, Jiangxi) |
| Trial ID | NCT06264804 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify the characteristics of patients who experience progressive suction loss during corneal refractive surgery compared to those who do not. By analyzing the differences between these two groups, the study seeks to uncover potential risk factors associated with suction loss. Participants will be evaluated based on their refractive stability, visual acuity, and other relevant criteria. The findings could help improve surgical outcomes and patient selection for refractive procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with stable refractive conditions and specific visual acuity requirements.
Not a fit: Patients with significant eye diseases, previous eye surgeries, or severe mental disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of corneal refractive surgeries for patients.
How similar studies have performed: While the approach is observational, similar studies have provided valuable insights into surgical outcomes, suggesting potential for meaningful findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years; 2. Stable refractive state in the last 2 years, with yearly change in refractive power ≤ 0.50 D; 3. Spherical power ≤ -10.00D, cylindrical power ≤ -3.00 D; 4. Best Corrected Visual Acuity (BCVA) ≥ 16/20; 5. No use of corneal contact lenses two weeks before surgery. Exclusion Criteria: 1. Eye diseases or histories beyond myopia and astigmatism, such as keratoconus; 2. Previous eye surgeries or histories of systemic illnesses; 3. Severe mental disorders like generalized anxiety disorder, panic disorder, depression, psychosis, and bipolar disorder, impeding cooperation with the doctor.
Where this trial is running
Nanchang, Jiangxi
- Yuyifeng — Nanchang, Jiangxi, China (Recruiting)
Study contacts
- Study coordinator: yifeng yu
- Email: 171018170@qq.com
- Phone: 13979180258
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.