A Prospective Study of Femtosecond Laser Intracorneal Lensectomi
NCT ID: NCT01673503
Last Updated: 2013-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
35 participants
INTERVENTIONAL
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Carl Zeiss Meditech VisuMax laser - ReLEx flex
\>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
Refractive lenticule extraction (ReLEx) with the Carl Zeiss Meditech VisuMax laser
Carl Zeiss Meditech VisuMax laser - ReLEx smile
\>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
Refractive lenticule extraction (ReLEx) with the Carl Zeiss Meditech VisuMax laser
Interventions
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Carl Zeiss Meditech VisuMax laser
Refractive lenticule extraction (ReLEx) with the Carl Zeiss Meditech VisuMax laser
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* moderate to high myopia with astigmatism =\< 2 D,
* otherwise eye healthy,
* CDVA of 0.8 or better (Snellen).
Exclusion Criteria
* thin cornea,
* a difference of more than 2 D myopia in the eyes of each subject.
25 Years
45 Years
ALL
Yes
Sponsors
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Aarhus University Hospital
OTHER
Odense University Hospital
OTHER
Responsible Party
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Anders H. Vestergaard
MD, PhD student
Principal Investigators
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Anders H Vestergaard, MD
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital, University of Southern Denmark
Locations
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Department of Ophthalmology Aarhus Sygehus - Aarhus University Hospital, Denmark
Aarhus, , Denmark
Countries
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References
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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.
Other Identifiers
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S-20100111
Identifier Type: -
Identifier Source: org_study_id
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