Using SMILE to correct high myopia
Official title: Clinical Results of Small Incision Lenticule Extraction (SMILE) for the Correction of High Myopia
Run by St. Franziskus Hospital · NCT04110067 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 5000 (estimated) |
| Sponsor | St. Franziskus Hospital Academic / other |
| Locations | 1 site (Münster, North Rhine-Westphalia) |
| Status | Recruiting |
| Started | January 2016 |
| Main results expected | November 2029 |
| Study ends | November 2029 |
| Registry record updated | November 29, 2024 |
| Trial ID | NCT04110067 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with high myopia exceeding -7.75 diopters and stable refractive measurements for over a year.
✕Probably not a fit
Patients with corneal irregular astigmatism or ectatic conditions may not benefit from this procedure.
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 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.
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 gone: Previous studies on SMILE have shown promising results, indicating its potential effectiveness for myopia correction.
Who can join: the full rules
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 it's running
-
Center for Refractive Surgery
Münster, North Rhine-Westphalia, Germany Recruiting
Study contacts
- Study coordinator: Suphi Taneri, MD
- Email: taneri@refraktives-zentrum.de
- Phone: +492519877890
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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.