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WithdrawnNCT01680354Updated May 2, 2014

Surgical Correction of Astigmatism

An interventional study of ReLEx and LASIK in Astigmatism, sponsored by Aarhus University Hospital. Withdrawn at 1 site in Denmark. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2014-05-02.

Sponsored by Aarhus University Hospital · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Institution changed surgical method to small incision lenticule extraction. Study never started.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
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Study 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.

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Conditions studied

  • Astigmatism

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03

In context

Astigmatism

413 studies on the registry are indexed under Astigmatism; 55 are open to participants now.

Browse Astigmatism studies →

Lead sponsor

Aarhus University Hospital is the lead sponsor of 289 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Subjects not fulfilling the above criteria
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    ReLEx

    One eye is treated with ReLEx the other with LASIK

    Procedure: ReLEx

  • Active comparator
    LASIK

    One eye is treated with ReLEx the other with LASIK

    Procedure: LASIK

Interventions

  • ProcedureReLEx

    Also known as: Device: Carl Zeiss Meditec Visumax Femtosecond Laser

  • ProcedureLASIK

    Also known as: Device: Carl Zeiss Meditec MEL-80 excimer laser

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What researchers measure

Primary outcomes

  1. Visual acuity

    Time frame: 1 year

Secondary outcomes

  1. Refraction

    Time frame: 1 year

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Study locations

1 site
  • Department of Ophthalmology, Aarhus University Hospital
    Aarhus, DK-8000, Denmark
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01680354
Lead sponsor
Aarhus University Hospital
Responsible party
Anders Ivarsen (MD, PhD, Aarhus University Hospital) — Principal investigator
First posted
Sep 7, 2012
Start date
Sep 2012
Primary completion
Sep 2012 (estimated)
Last update
May 2, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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