MedPath

Wavefront-guided LASIK for Correction of Myopia

Not Applicable
Withdrawn
Conditions
Myopia
Registration Number
NCT01682434
Lead Sponsor
Aarhus University Hospital
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Visual acuity12 months
Secondary Outcome Measures
NameTimeMethod
Ocular higher order aberrations12 months

Hartmann-Schack wavefront aberrometry using the Zeiss Meditec WASCA

Trial Locations

Locations (1)

Department of Ophthalmology, Aarhus University Hospital

🇩🇰

Aarhus, Denmark

Department of Ophthalmology, Aarhus University Hospital
🇩🇰Aarhus, Denmark

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.