MyopiaNCT04110067
Clinical Results of Small Incision Lenticule Extraction (SMILE) for the Correction of High Myopia
An observational study of Myopia and High Myopia, run by Suphi Taneri at 1 site in Germany.
Trial summary
Small Incision Lenticule Extraction (SMILE) was introduced in 2011 using the VISUMAX femtosecond laser (Carl Zeiss Meditec, Jena, Germany). It is designed for correction of myopia and myopic astigmatism. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia, High Myopia
- What is being tested?
- Small Incision Lenticule Extraction (SMILE) with Visumax (Carl Zeiss Meditec, Jena)
- How many people
- 5,000 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2016to Nov 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients with myopia more than -7.75 D seeking refractive surgery
Who may be able to join
- adults
- myopia more than -7.75 D
- refractive stability more than 1 year
Who cannot join
- corneal irregular astigmatism
- ectatic conditions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Center for Refractive Surgery
Münster, North Rhine-Westphalia, 48145
Suphi Taneri, MD, +492519877890, taneri@refraktives-zentrum.de
About this study
Small Incision Lenticule Extraction (SMILE) was introduced in 2011 using the VISUMAX femtosecond laser (Carl Zeiss Meditec, Jena, Germany). It is designed for correction of myopia and myopic astigmatism.
It involves the creation of a corneal tissue disk called lenticule and its extraction through a minimally invasive incision, utilizing only a femtosecond laser. This enables rapid visual recovery with very little discomfort to the patient.
Read more
This observational case series monitors visual and refractive outcomes of myopic correction for more than -7.75 D.
It is to
- gather long-term results and refractive stability
- detect rare complications or side-effects
- evaluate the efficacy in a large number of patients
- Conditions
- Myopia, High Myopia
- Being tested
- Small Incision Lenticule Extraction (SMILE) with Visumax (Carl Zeiss Meditec, Jena)
- Keywords
- Myopia, Refractive Surgery, Small Incision Lenticule Extraction, SMILE
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small Incision Lenticule Extraction (SMILE) with Visumax (Carl Zeiss Meditec, Jena)Other
Also called RelaxSmile
Creation of a corneal tissue disk called lenticule and extraction through a minimally invasive incision, utilizing only a femtosecond laser
| Study group | Role | What they receive |
|---|---|---|
| 1 | SMILE - Correction of eyes with myopia of more than -7.75 D Receives: Other: Small Incision Lenticule Extraction (SMILE) with Visumax (Carl Zeiss Meditec, Jena) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Distance Refraction
Subjective Refraction
Measured: 1 year
Distance Visual Acuity
Visual Acuity sine and cum correctione
Measured: 1 year
Secondary outcomes (2)
Tectonic stability as assessed by Pentacam
Corneal tectonic stability post surgery as assesed by Scheimpflug-Tomography
Measured: 1 year
Epithelial thickness map in Optical coherence tomography
Change of Thickness of epithelium pre and post surgery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study startJan 2016
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suphi Taneri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Suphi Taneri, St. Franziskus Hospital
- Investigators
- Suphi Taneri, MD, Study chair, Center for Refractive Surgery Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110067
- Sponsor's protocol ID
- SMILE > 7.75D
- Status last verified
- Nov 2024
- First submitted
- 26 Sep 2019
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Results of Small Incision Lenticule Extraction (SMILE) for the Correction of High Myopia
- ClinicalTrials.gov ID
- NCT04110067
- Acronym / sponsor ID
- SMILE > 7.75D
- Conditions
- Myopia, High Myopia
- Keywords
- Myopia, Refractive Surgery, Small Incision Lenticule Extraction, SMILE
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Suphi TaneriUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 1 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Small Incision Lenticule Extraction (SMILE) was introduced in 2011 using the VISUMAX femtosecond laser (Carl Zeiss Meditec, Jena, Germany). It is designed for correction of myopia and myopic astigmatism.
It involves the creation of a corneal tissue disk called lenticule and its extraction through a minimally invasive incision, utilizing only a femtosecond laser. This enables rapid visual recovery with very little discomfort to the patient.
This observational case series monitors visual and refractive outcomes of myopic correction for more than -7.75 D.
It is to
- gather long-term results and refractive stability
- detect rare complications or side-effects
- evaluate the efficacy in a large number of patients
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Small Incision Lenticule Extraction (SMILE) with Visumax (Carl Zeiss Meditec, Jena)SMILE - Correction of eyes with myopia of more than -7.75 D |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with myopia more than -7.75 D seeking refractive surgery
Key inclusion criteria (3 listed)
- adults
- myopia more than -7.75 D
- refractive stability more than 1 year
Key exclusion criteria (2 listed)
- corneal irregular astigmatism
- ectatic conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Small Incision Lenticule Extraction (SMILE) with Visumax (Carl Zeiss Meditec, Jena)Also: RelaxSmileCreation of a corneal tissue disk called lenticule and extraction through a minimally invasive incision, utilizing only a femtosecond laser | Other | 1 |
Primary outcome
Subjective Distance Refraction
Time frame: 1 year
Subjective Refraction
Distance Visual Acuity
Time frame: 1 year
Visual Acuity sine and cum correctione
2 secondary outcomes
Tectonic stability as assessed by Pentacam
Time frame: 1 year
Epithelial thickness map in Optical coherence tomography
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suphi Taneri, MD study chair
Center for Refractive Surgery Muenster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia and High Myopia, run by Suphi Taneri at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suphi Taneri, MD (+492519877890, taneri@refraktives-zentrum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Distance Refraction (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.