Surgical Correction of Astigmatism

NCT ID: NCT01680354

Last Updated: 2014-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Astigmatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ReLEx

One eye is treated with ReLEx the other with LASIK

Group Type ACTIVE_COMPARATOR

ReLEx

Intervention Type PROCEDURE

LASIK

One eye is treated with ReLEx the other with LASIK

Group Type ACTIVE_COMPARATOR

LASIK

Intervention Type PROCEDURE

Interventions

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ReLEx

Intervention Type PROCEDURE

LASIK

Intervention Type PROCEDURE

Other Intervention Names

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Device: Carl Zeiss Meditec Visumax Femtosecond Laser Device: Carl Zeiss Meditec MEL-80 excimer laser

Eligibility Criteria

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Inclusion Criteria

* Myopic astigmatism between -2.0 and -5.0 diopters
* Maximal difference in spherical equivalent refraction of 2 D between eyes
* No ocular or systemic disease
* Not pregnant or breastfeeding
* Minimum BSCVA of 0.8 (decimal)
* Normal corneal topography
* Sufficient corneal thickness to allow the treatment

Exclusion Criteria

* Subjects not fulfilling the above criteria
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anders Ivarsen

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Ophthalmology, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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AUH_ASTIGMATISM

Identifier Type: -

Identifier Source: org_study_id

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