Wavefront-guided LASIK for Correction of Myopia

Myopia Clinical Trial

Official title:

Wavefront-guided LASIK for Correction of Myopia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01682434
• Other study ID #: AUH_LASIK
• Status: Withdrawn
• Phase: N/A
• First received: September 4, 2012
• Last updated: April 30, 2014
• Start date: May 2011

Study information

• Verified date: April 2014
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Procedure:
• Laser in situ keratomileusis (LASIK)
Wavefront guided treatment in one eye, conventional in the other.

Locations

Country	Name	City	State
Denmark	Department of Ophthalmology, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity		12 months	Yes
Secondary	Ocular higher order aberrations	Hartmann-Schack wavefront aberrometry using the Zeiss Meditec WASCA	12 months	No