Myopia
Conditions
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.
Interventions
PROCEDURELaser in situ keratomileusis (LASIK)
Wavefront guided treatment in one eye, conventional in the other.
Sponsors
Aarhus University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Patients that do not fulfill inclusion criteria * Insufficient quality of ocular wavefront measurement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual acuity | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ocular higher order aberrations | 12 months | Hartmann-Schack wavefront aberrometry using the Zeiss Meditec WASCA |
Countries
Denmark
Outcome results
None listed