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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
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The purpose of this study is to compare visual acuity, safety, predictability, corneal biomechanics, dry eyes, and nerve-morphology after all femtosecond laser refractive lenticule extraction. Approximately 30 to 40 patients with moderate to high myopia will randomly (after ocular dominance) receive ReLEx flex in one eye, and ReLEx smile in the other.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carl Zeiss Meditech VisuMax laser - ReLEx flex | Active Comparator | >30 patients will receive treatment for myopia with a VisuMax femtosecond laser from Carl Zeiss. The laser can cut with two different settings, called ReLEx flex and ReLEx smile. One eye will recieve ReLEx flex, and the other ReLEx smile |
|
| Carl Zeiss Meditech VisuMax laser - ReLEx smile | Active Comparator | >30 patients will receive treatment for myopia with a VisuMax femtosecond laser from Carl Zeiss. The laser can cut with two different settings, called ReLEx flex and ReLEx smile. One eye will recieve ReLEx flex, and the other ReLEx smile |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carl Zeiss Meditech VisuMax laser | Device | Refractive lenticule extraction (ReLEx) with the Carl Zeiss Meditech VisuMax laser |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity | Using ETDRS charts, both uncorrected and corrected distance visual acuity, along with visual acuity using the FrACT contrast chart | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| refractive predictability | Optometrists measure refraction at follow-up-examinations, and the refraction 6 monhts after surgery will be compared to the target refraction to calculate refractive predictability | Pre-surgery, 1 week, 1 month, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal biomechanics, corneal nerve changes and dry eye symptoms | Corneal hysteresis and corneal resistence factor using the Ocular response analyser, nerve changes using the Cochet-Bonnet Aesthesiometer and confokal mikroscopy, and dry eyes symptoms using Schirmers test, Tear BUT, and Oculus keratograph, along with anterior segment OCT to measure tear meniscus hight. | pre-surgery and 6 months after |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders H Vestergaard, MD | Odense University Hospital, University of Southern Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology Aarhus Sygehus - Aarhus University Hospital, Denmark | Aarhus | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23793872 | Derived | Vestergaard AH, Gronbech KT, Grauslund J, Ivarsen AR, Hjortdal JO. Subbasal nerve morphology, corneal sensation, and tear film evaluation after refractive femtosecond laser lenticule extraction. Graefes Arch Clin Exp Ophthalmol. 2013 Nov;251(11):2591-600. doi: 10.1007/s00417-013-2400-x. Epub 2013 Jun 22. |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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