Clinical trial NCT04884672: PMCF Study on SMILE Treatment of Myopia With and Without Astigmatism
Official title: Post-Market Clinical Follow-up Study on SMILE Treatment of Myopia With and Without Astigmatism by VISUMAX 800
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Astigmatism
Keywords: SMILE
Myopia
Astigmatism
Lead sponsor: Carl Zeiss Meditec AG
Sponsor class: INDUSTRY
Collaborators: name: In Vitro Research Solutions Pvt Ltd (iVRS)
First posted: 2021-05-13
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population for the device are patients with myopia and myopia combined with astigmatism, who are medically suitable for femtosecond laser treatment with the SMILE treatment.

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 market surveillance.

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 the VISUMAX 800 femtosecond laser in daily routine use.

In this PMCF study, at maximum 474 eyes of consecutive subjects will be consented, enrolled, treated and followed up to 6 months postoperatively at 4 to 5 sites. The treatments, which will be done bilateral, shall be equally distributed between the sites as far as possible.

The subjects will be 18 years of age or older, who suffer from myopia of up to -10 D with or without astigmatism of up to 5 D, and are suitable for SMILE treatments, fulfil all inclusion criteria and not fulfil any of the exclusion criteria.

The expected duration of the is 16 months (site initiation to closeout visit).

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Accuracy of manifest spherical equivalent
timeFrame: 1 week
measure: Accuracy of manifest spherical equivalent
timeFrame: 1 month
measure: Accuracy of manifest spherical equivalent
timeFrame: 3 months
measure: Accuracy of manifest spherical equivalent
timeFrame: 6 months
measure: Accuracy of astigmatism
timeFrame: 1 week
measure: Accuracy of astigmatism
timeFrame: 1 month
measure: Accuracy of astigmatism
timeFrame: 3 months
measure: Accuracy of astigmatism
timeFrame: 6 months
measure: Early visual acuity
timeFrame: 1 day
measure: Early visual acuity
timeFrame: 1 week
measure: Side effects and complications
timeFrame: 1 day
measure: Side effects and complications
timeFrame: 1 week
measure: Side effects and complications
timeFrame: 1 month
measure: Side effects and complications
timeFrame: 3 months
measure: Side effects and complications
timeFrame: 6 months
Secondary outcomes:
measure: CDVA
timeFrame: 1 week
measure: CDVA
timeFrame: 1 month
measure: CDVA
timeFrame: 3 months
measure: CDVA
timeFrame: 6 months
measure: Mesopic contrast sensitivity
timeFrame: 6 months
measure: UDVA
timeFrame: 1 day
measure: UDVA
timeFrame: 1 week
measure: UDVA
timeFrame: 1 month
measure: UDVA
timeFrame: 3 months
measure: UDVA
timeFrame: 6 months
measure: Predictability and accuracy
timeFrame: 1 week
measure: Predictability and accuracy
timeFrame: 1 month
measure: Predictability and accuracy
timeFrame: 3 months
measure: Predictability and accuracy
timeFrame: 6 months
measure: Stability
timeFrame: between 1 month 3 months
measure: Stability
timeFrame: between 3 months and 6 months
measure: Cylinder vector analyses
timeFrame: 1 week
measure: Cylinder vector analyses
timeFrame: 1 month
measure: Cylinder vector analyses
timeFrame: 3 months
measure: Cylinder vector analyses
timeFrame: 6 months
measure: Patient Questionnaire
timeFrame: 6 months
measure: Corneal wave-front, change against baseline
timeFrame: 6 months
measure: Centration
timeFrame: during the procedure
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Clinical Medicine - Department of Ophthalmology
city: Marburg
country: Germany
facility: University Medical Center Universitätsklinikum Gießen Marburg
city: München
country: Germany
facility: Smile Eyes Airport München
city: Hong Kong
country: Hong Kong
facility: HKSH Healthcare Guy Hugh Chan Refractive Surgery Centre
city: Bangalore
country: India
facility: Medical Center Nethradhama Superspeciality Eye Hospital
Study officials:
affiliation: Department of Clinical Medicine - Department of Ophthalmology
name: Jesper Hjortdal, Prof.
role: PRINCIPAL_INVESTIGATOR
References: