Study Stopped
Institution changed surgical method to small-incision lenticule extraction. Study never started.
Wavefront-guided LASIK for Correction of Myopia
1 other identifier
interventional
N/A
1 country
1
Brief Summary
Laser in situ keratomileusis is a successful procedure for the treatment of low to moderate myopia. Advances over the last decade have allowed LASIK to also correct higher order wavefront aberrations. In low myopia, there seem to be a minor effect of such wavefront-guided treatment. However, it remains to be established whether there is a beneficial effect in higher degrees of myopia. The study aims to determine whether myopic subjects (-6 to -10 diopters) with higher-than-average preoperative higher-order aberrations have benefit of wavefront-guided treatment. Subjects are randomized to wavefront-guided treatment in one eye, and conventional treatment in the other.
Trial Health
Trial Health Score
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1 active site
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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
September 4, 2012
CompletedFirst Posted
Study publicly available on registry
September 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedMay 2, 2014
April 1, 2014
2.7 years
September 4, 2012
April 30, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Visual acuity
12 months
Secondary Outcomes (1)
Ocular higher order aberrations
12 months
Study Arms (2)
Wavefront-guided LASIK
ACTIVE COMPARATOROne eye will be randomized to wavefront-guided treatment. The other receives conventional LASIK.
Conventional LASIK
ACTIVE COMPARATOROne eye will receive wavefront-guided LASIK. The other eye receives conventional treatment.
Interventions
Wavefront guided treatment in one eye, conventional in the other.
Eligibility Criteria
You may qualify if:
- Age 20 to 50 years
- No known ocular or systemic disease
- Not pregnant or breastfeeding
- Myopia between -6.0 and -10.0 diopters
- Astigmatism below 2.0 diopters
- Difference of less than 1.0 diopters in spherical equivalent between eyes
- Normal corneal topography
- Corneal thickness sufficient for planned treatment
You may not qualify if:
- Insufficient quality of ocular wavefront measurement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Ophthalmology, Aarhus University Hospital
Aarhus, DK-8000, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anders Ivarsen, MD, PhD
Aarhus University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
September 4, 2012
First Posted
September 11, 2012
Study Start
May 1, 2011
Primary Completion
January 1, 2014
Last Updated
May 2, 2014
Record last verified: 2014-04