Wavefront-guided LASIK for Correction of Myopia

NCT ID: NCT01682434

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WITHDRAWN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

2011-05-31

Brief Summary

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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

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Wavefront-guided LASIK

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

Group Type ACTIVE_COMPARATOR

Laser in situ keratomileusis (LASIK)

Intervention Type PROCEDURE

Wavefront guided treatment in one eye, conventional in the other.

Conventional LASIK

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

Group Type ACTIVE_COMPARATOR

Laser in situ keratomileusis (LASIK)

Intervention Type PROCEDURE

Wavefront guided treatment in one eye, conventional in the other.

Interventions

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Laser in situ keratomileusis (LASIK)

Wavefront guided treatment in one eye, conventional in the other.

Intervention Type PROCEDURE

Other Intervention Names

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Device: Carl Zeiss Meditec Visumax femtosecond LASIK Device: Carl Zeiss Meditec MEL-80 excimer laser.

Eligibility Criteria

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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

* Insufficient quality of ocular wavefront measurement
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

Principal Investigators

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Anders Ivarsen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

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_LASIK

Identifier Type: -

Identifier Source: org_study_id

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