Health Condition 1: H522- Astigmatism Health Condition 2: H521- Myopia
Conditions
Interventions
Intervention1: Standard SMILE technique: Standard SMILE technique
performed using standard laser
settings
Frequency: 2 MHz
Control Intervention1: NIL: NIL
Sponsors
Carl Zeiss Meditec AG
Eligibility
Inclusion criteria
Inclusion criteria: -Myopia up to -10 D with and without astigmatism up to 5D. -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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Determination of the percentage of eyes with post-operative spherical equivalent (minus target spherical equivalent) within ±0.5 D with an accuracy of ±4% post-operatively. 2)Determination of the percentage of eyes with a post-operative astigmatism =0.5 D with an accuracy of ±4% post-operatively. 3)Determination of the mean difference of post-operative UDVA minus pre-operative CDVA with a half width of their 95%-confidence interval of 0.02 logMAR or lowerTimepoint: 1 week, 1 month, 3 months and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| -Distribution of CDVA change against baseline for all post-op visits (except 1day) -Cumulative distribution of post-operative CDVA for all post-op visits -Distribution of pre-op and post-op manifest astigmatism -Pre-op and 6-month post-op mesopic contrast sensitivity and their difference -Cumulative distribution of post-op UDVA (compared to pre-op CDVA)Timepoint: 1 week, 1 month, 3 months and 6 months | — |
Countries
Denmark, Germany, Hong Kong, India, United Kingdom
Contacts
Public ContactMr T Vijay Bhaskar
Nethradhama Superspeciality Eye Hospital
Outcome results
None listed