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Surgical Correction of Astigmatism

Comparative Study of Surgical Laser Correction of Astigmatism

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01680354
Enrollment
0
Registered
2012-09-07
Start date
2012-09-30
Completion date
Unknown
Last updated
2014-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Astigmatism

Brief summary

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.

Interventions

PROCEDUREReLEx
PROCEDURELASIK

Sponsors

Aarhus University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Visual acuity1 year

Secondary

MeasureTime frame
Refraction1 year

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026