Clinical trial Recruiting at 1 site Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment5000 (estimated)
SponsorSt. Franziskus Hospital
Academic / other
Locations1 site (Münster, North Rhine-Westphalia)
StatusRecruiting
StartedJanuary 2016
Main results expectedNovember 2029
Study endsNovember 2029
Registry record updatedNovember 29, 2024
Trial IDNCT04110067 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.