Surgical Correction of Astigmatism

Aarhus University Hospital

Status: Withdrawn

Conditions: Astigmatism

Treatments: Procedure: LASIK; Procedure: ReLEx

Study type: Interventional

Funder types: Other

Identifiers

NCT01680354

AUH_ASTIGMATISM

Details and patient eligibility

About

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.

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

ReLEx

Active Comparator group

Description:

One eye is treated with ReLEx the other with LASIK

Treatment:

Procedure: ReLEx

LASIK

Active Comparator group

Description:

One eye is treated with ReLEx the other with LASIK

Treatment:

Procedure: LASIK