A Prospective Study of Femtosecond Laser Intracorneal Lensectomi
1 other identifier
interventional
35
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 20, 2012
CompletedFirst Posted
Study publicly available on registry
August 28, 2012
CompletedJanuary 24, 2013
January 1, 2013
August 20, 2012
January 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
refractive predictability
Pre-surgery, 1 week, 1 month, 3 months, 6 months
Other Outcomes (1)
Corneal biomechanics, corneal nerve changes and dry eye symptoms
pre-surgery and 6 months after
Study Arms (2)
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
Interventions
Refractive lenticule extraction (ReLEx) with the Carl Zeiss Meditech VisuMax laser
Eligibility Criteria
You may qualify if:
- to 45 years,
- moderate to high myopia with astigmatism =\< 2 D,
- otherwise eye healthy,
- CDVA of 0.8 or better (Snellen).
You may not qualify if:
- systemic or ocular disease or previous eye surgery,
- thin cornea,
- a difference of more than 2 D myopia in the eyes of each subject.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Odense University Hospitallead
- Aarhus University Hospitalcollaborator
Study Sites (1)
Department of Ophthalmology Aarhus Sygehus - Aarhus University Hospital, Denmark
Aarhus, 8000, Denmark
Related Publications (1)
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.
PMID: 23793872DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anders H Vestergaard, MD
Odense University Hospital, University of Southern Denmark
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD student
Study Record Dates
First Submitted
August 20, 2012
First Posted
August 28, 2012
Study Start
May 1, 2011
Last Updated
January 24, 2013
Record last verified: 2013-01