Suspended

Comparative Study of Surgical Laser Correction of Astigmatism

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What is being tested

ReLEx

+ LASIK

Procedure
Who is being recruted

Eye Diseases

+ Refractive Errors

+ Astigmatism

From 20 to 50 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2012
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: September 1, 2012

Actual date on which the first participant was enrolled.

Laser correction for myopia and astigmatism using an excimer laser has been performed with success for several years. During the last 2 years, a new method for correction of refractive errors has emerged. In the method (ReLex) a femtosecond laser is used to cut a lenticule in the corneal stroma that is subsequently removed. For simple myopia this method has proved effective and on par with excimer baser LASIK. However, it remains to be determined if ReLEx is as effective in the treatment of astigmatism. In the study, patients with high astigmatism are treated with conventional LASIK for astigmatism in one eye and with ReLEx for astigmatism in the other.

NCT01680354
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 ErrorsAstigmatism

Criteria

7 inclusion criteria required to participate
Maximal difference in spherical equivalent refraction of 2 D between eyes
Minimum BSCVA of 0.8 (decimal)
Myopic astigmatism between -2.0 and -5.0 diopters
No ocular or systemic disease
Show More Criteria
1 exclusion criteria prevent from participating
Subjects not fulfilling the above criteria

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 is treated with ReLEx the other with LASIK

Group II

Active Comparator
One eye is treated with ReLEx the other with LASIK

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