Status:
COMPLETED
PMCF Study on SMILE Treatment of Myopia With and Without Astigmatism
Lead Sponsor:
Carl Zeiss Meditec AG
Collaborating Sponsors:
In Vitro Research Solutions Pvt Ltd (iVRS)
Conditions:
Myopia
Astigmatism
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective of this PMCF investigation is to systematically collect safety and effectiveness data with the VISUMAX 800 laser in clinical daily routine SMILE use for the purpose of post marke...
Detailed Description
The present PMCF study is a prospective, non-randomized, international multi-center study without control group including patients with myopia or myopia combined with astigmatism undergoing SMILE with...
Eligibility Criteria
Inclusion
- Myopia up to -10 D with and without astigmatism up to 5 D
- Age of 18 years or older
- Pre-operative CDVA of 20/25 or better in each eye
- Patient shall be willing to comply with all follow-up visits and the respective examinations
- Patients should be able to understand the patient information and willing to sign an informed consent.
- Contact lens wearers must stop wearing their contact lenses at least 2 weeks before baseline measurements in case of hard contact lenses and 2 days before baseline measurements in case of soft contact lenses
Exclusion
- No monovision treatments (target sphere may not be more negative than -0.25 D)
- The patient may not participate in other ophthalmologic studies except in VEMOS study at site Aarhus.
- Any impaired person (minors, pregnant or breast-feeding women or persons incapable of giving consent) are definitely excluded from the study.
- The patients presenting at least one of the contraindications stated in User Manual of the VISUMAX 800 option ReLEx SMILE must not be included in this clinical investigation
Key Trial Info
Start Date :
July 9 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 25 2023
Estimated Enrollment :
237 Patients enrolled
Trial Details
Trial ID
NCT04884672
Start Date
July 9 2021
End Date
March 25 2023
Last Update
October 23 2023
Active Locations (5)
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1
Department of Clinical Medicine - Department of Ophthalmology
Aarhus, Denmark, 8200
2
University Medical Center Universitätsklinikum Gießen Marburg
Marburg, Germany
3
Smile Eyes Airport München
München, Germany, 85356
4
HKSH Healthcare Guy Hugh Chan Refractive Surgery Centre
Hong Kong, Hong Kong