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Wavefront-guided LASIK for Correction of Myopia

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What is being tested

Laser in situ keratomileusis (LASIK)

+ Laser in situ keratomileusis (LASIK)

Procedure
Who is being recruted

Eye Diseases

+ Refractive Errors

+ Myopia

From 20 to 50 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: May 2011
See protocol details

Summary

Principal SponsorAarhus University Hospital
Last updated: May 2, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2011

Actual date on which the first participant was enrolled.

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.

NCT01682434
Principal SponsorAarhus University Hospital
Last updated: May 2, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesRefractive ErrorsMyopia

Criteria

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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
One eye will be randomized to wavefront-guided treatment. The other receives conventional LASIK.

Group II

Active Comparator
One eye will receive wavefront-guided LASIK. The other eye receives conventional treatment.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Department of Ophthalmology, Aarhus University Hospital

Aarhus, DenmarkOpen Department of Ophthalmology, Aarhus University Hospital in Google Maps
SuspendedOne Study Center