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Surgical Correction of Astigmatism

Primary Purpose

Astigmatism

Status
Withdrawn
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
ReLEx
LASIK
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astigmatism

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Ophthalmology, Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ReLEx

LASIK

Arm Description

One eye is treated with ReLEx the other with LASIK

One eye is treated with ReLEx the other with LASIK

Outcomes

Primary Outcome Measures

Visual acuity

Secondary Outcome Measures

Refraction

Full Information

First Posted
September 4, 2012
Last Updated
April 30, 2014
Sponsor
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01680354
Brief Title
Surgical Correction of Astigmatism
Official Title
Comparative Study of Surgical Laser Correction of Astigmatism
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Institution changed surgical method to small incision lenticule extraction. Study never started.
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ReLEx
Arm Type
Active Comparator
Arm Description
One eye is treated with ReLEx the other with LASIK
Arm Title
LASIK
Arm Type
Active Comparator
Arm Description
One eye is treated with ReLEx the other with LASIK
Intervention Type
Procedure
Intervention Name(s)
ReLEx
Other Intervention Name(s)
Device: Carl Zeiss Meditec Visumax Femtosecond Laser
Intervention Type
Procedure
Intervention Name(s)
LASIK
Other Intervention Name(s)
Device: Carl Zeiss Meditec MEL-80 excimer laser
Primary Outcome Measure Information:
Title
Visual acuity
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Refraction
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Ophthalmology, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
DK-8000
Country
Denmark

12. IPD Sharing Statement

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Surgical Correction of Astigmatism

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