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Wavefront-guided LASIK for Correction of Myopia

Primary Purpose

Myopia

Status
Withdrawn
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Laser in situ keratomileusis (LASIK)
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

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

Inclusion Criteria:

  • Age 20 to 50 years
  • No known ocular or systemic disease
  • Not pregnant or breastfeeding
  • Myopia between -6.0 and -10.0 diopters
  • Astigmatism below 2.0 diopters
  • Difference of less than 1.0 diopters in spherical equivalent between eyes
  • Normal corneal topography
  • Corneal thickness sufficient for planned treatment

Exclusion Criteria:

  • Patients that do not fulfill inclusion criteria
  • Insufficient quality of ocular wavefront measurement

Sites / Locations

  • Department of Ophthalmology, Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Wavefront-guided LASIK

Conventional LASIK

Arm Description

One eye will be randomized to wavefront-guided treatment. The other receives conventional LASIK.

One eye will receive wavefront-guided LASIK. The other eye receives conventional treatment.

Outcomes

Primary Outcome Measures

Visual acuity

Secondary Outcome Measures

Ocular higher order aberrations
Hartmann-Schack wavefront aberrometry using the Zeiss Meditec WASCA

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
NCT01682434
Brief Title
Wavefront-guided LASIK for Correction of Myopia
Official Title
Wavefront-guided LASIK for Correction of Myopia
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Withdrawn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
May 2011 (undefined)
Primary Completion Date
January 2014 (Actual)
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 in situ keratomileusis is a successful procedure for the treatment of low to moderate myopia. Advances over the last decade have allowed LASIK to also correct higher order wavefront aberrations. In low myopia, there seem to be a minor effect of such wavefront-guided treatment. However, it remains to be established whether there is a beneficial effect in higher degrees of myopia. The study aims to determine whether myopic subjects (-6 to -10 diopters) with higher-than-average preoperative higher-order aberrations have benefit of wavefront-guided treatment. Subjects are randomized to wavefront-guided treatment in one eye, and conventional treatment in the other.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wavefront-guided LASIK
Arm Type
Active Comparator
Arm Description
One eye will be randomized to wavefront-guided treatment. The other receives conventional LASIK.
Arm Title
Conventional LASIK
Arm Type
Active Comparator
Arm Description
One eye will receive wavefront-guided LASIK. The other eye receives conventional treatment.
Intervention Type
Procedure
Intervention Name(s)
Laser in situ keratomileusis (LASIK)
Other Intervention Name(s)
Device: Carl Zeiss Meditec Visumax femtosecond LASIK, Device: Carl Zeiss Meditec MEL-80 excimer laser.
Intervention Description
Wavefront guided treatment in one eye, conventional in the other.
Primary Outcome Measure Information:
Title
Visual acuity
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Ocular higher order aberrations
Description
Hartmann-Schack wavefront aberrometry using the Zeiss Meditec WASCA
Time Frame
12 months

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: Age 20 to 50 years No known ocular or systemic disease Not pregnant or breastfeeding Myopia between -6.0 and -10.0 diopters Astigmatism below 2.0 diopters Difference of less than 1.0 diopters in spherical equivalent between eyes Normal corneal topography Corneal thickness sufficient for planned treatment Exclusion Criteria: Patients that do not fulfill inclusion criteria Insufficient quality of ocular wavefront measurement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Ivarsen, MD, PhD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
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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Wavefront-guided LASIK for Correction of Myopia

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