NCT01680354

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2012

Completed
Last Updated

May 2, 2014

Status Verified

April 1, 2014

Enrollment Period

Same day

First QC Date

September 4, 2012

Last Update Submit

April 30, 2014

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    1 year

Secondary Outcomes (1)

  • Refraction

    1 year

Study Arms (2)

ReLEx

ACTIVE COMPARATOR

One eye is treated with ReLEx the other with LASIK

Procedure: ReLEx

LASIK

ACTIVE COMPARATOR

One eye is treated with ReLEx the other with LASIK

Procedure: LASIK

Interventions

ReLExPROCEDURE
Also known as: Device: Carl Zeiss Meditec Visumax Femtosecond Laser
ReLEx
LASIKPROCEDURE
Also known as: Device: Carl Zeiss Meditec MEL-80 excimer laser
LASIK

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Subjects not fulfilling the above criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Aarhus University Hospital

Aarhus, DK-8000, Denmark

Location

MeSH Terms

Conditions

Astigmatism

Interventions

Keratomileusis, Laser In Situ

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Corneal Surgery, LaserLaser TherapyTherapeuticsAblation TechniquesSurgical Procedures, OperativeKeratectomyRefractive Surgical ProceduresOphthalmologic Surgical Procedures
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 4, 2012

First Posted

September 7, 2012

Study Start

September 1, 2012

Primary Completion

September 1, 2012

Last Updated

May 2, 2014

Record last verified: 2014-04

Locations

DK(1)