Wavefront-guided LASIK for Correction of Myopia

Aarhus University Hospital

Status: Withdrawn

Conditions: Myopia

Treatments: Procedure: Laser in situ keratomileusis (LASIK)

Study type: Interventional

Funder types: Other

Identifiers

NCT01682434

AUH_LASIK

Details and patient eligibility

About

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.

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Wavefront-guided LASIK

Active Comparator group

Description:

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

Treatment:

Procedure: Laser in situ keratomileusis (LASIK)

Conventional LASIK

Active Comparator group

Description:

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

Treatment:

Procedure: Laser in situ keratomileusis (LASIK)