Using SMILE to correct high myopia
Clinical Results of Small Incision Lenticule Extraction (SMILE) for the Correction of High Myopia
This study is testing if a new eye surgery called SMILE can help people with very poor eyesight (high myopia) see better and recover quickly.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Franziskus Hospital Academic / other |
| Locations | 1 site (Münster, North Rhine-Westphalia) |
| Trial ID | NCT04110067 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of Small Incision Lenticule Extraction (SMILE) for correcting high myopia, specifically in patients with refractive errors greater than -7.75 diopters. The procedure involves creating and extracting a lenticule from the cornea using a femtosecond laser, which aims to provide rapid visual recovery with minimal discomfort. The study will monitor long-term visual and refractive outcomes, assess the stability of results, and identify any rare complications or side effects associated with the procedure.
Who should consider this trial
Good fit: Ideal candidates are adults with high myopia exceeding -7.75 diopters and stable refractive measurements for over a year.
Not a fit: Patients with corneal irregular astigmatism or ectatic conditions may not benefit from this procedure.
Why it matters
Potential benefit: If successful, this approach could significantly improve vision and quality of life for patients with high myopia.
How similar studies have performed: Previous studies on SMILE have shown promising results, indicating its potential effectiveness for myopia correction.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * adults * myopia more than -7.75 D * refractive stability more than 1 year Exclusion Criteria: * corneal irregular astigmatism * ectatic conditions
Where this trial is running
Münster, North Rhine-Westphalia
- Center for Refractive Surgery — Münster, North Rhine-Westphalia, Germany (Recruiting)
Study contacts
- Study coordinator: Suphi Taneri, MD
- Email: taneri@refraktives-zentrum.de
- Phone: +492519877890
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.