Wavefront-guided LASIK for Correction of Myopia

Not Applicable

Withdrawn

• Conditions: Myopia
• Interventions: Procedure: Laser in situ keratomileusis (LASIK)

• 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

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2012-09-04
• Study First Submitted QC: 2012-09-10
• Study First Posted: 2012-09-11
• Primary Completion: 2014-01
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-30
• Last Update Posted: 2014-05-02

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• Status: WITHDRAWN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

Arm && Interventions

Group	Intervention	Description
Wavefront-guided LASIK	Laser in situ keratomileusis (LASIK)	One eye will be randomized to wavefront-guided treatment. The other receives conventional LASIK.
Conventional LASIK	Laser in situ keratomileusis (LASIK)	One eye will receive wavefront-guided LASIK. The other eye receives conventional treatment.

Primary Outcome Measures

Name	Time	Method
Visual acuity	12 months

Secondary Outcome Measures

Name	Time	Method
Ocular higher order aberrations	12 months	Hartmann-Schack wavefront aberrometry using the Zeiss Meditec WASCA

Trial Locations

Locations (1)

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