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A Comparison of Fellow Eyes Undergoing LASIK or PRK With a Wavefront-guided Excimer Laser Versus a Wavefront-optimized Excimer Laser

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Edward E. Manche, Stanford University
ClinicalTrials.gov Identifier:
NCT01135719
First received: May 8, 2009
Last updated: May 3, 2012
Last verified: May 2012
History of Changes

May 8, 2009
May 3, 2012
April 2009
March 2013   (final data collection date for primary outcome measure)
  • Changes in best spectacle corrected visual acuity. [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Changes in 25 and 5% low contrast visual acuity. [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Improvement in uncorrected visual acuity [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01135719 on ClinicalTrials.gov Archive Site
  • Changes in higher order aberrations. [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Topographic changes. [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Quality of vision changes. [ Time Frame: One year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Comparison of Fellow Eyes Undergoing LASIK or PRK With a Wavefront-guided Excimer Laser Versus a Wavefront-optimized Excimer Laser
A Prospective Randomized Comparison of Fellow Eyes Undergoing LASIK or PRK With a Wavefront-guided Excimer Laser Versus a Wavefront-optimized Excimer Laser

Subjects with myopia, hyperopia and astigmatism are being randomized to be treated in one eye with a wavefront-guided excimer laser and their fellow eye treated with a wavefront-optimized excimer laser.

Subjects with myopia, hyperopia and astigmatism are being randomized by ocular dominance to be treated with either PRK or LASIK. One eye will be treated with a wavefront-guided excimer laser and the fellow eye will be treated with a wavefront optimized excimer laser.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hyperopia
  • Myopia
  • Astigmatism
Procedure: LASIK and PRK
Wavefront-guided versus wavefront-optimized LASIK or PRK.
Other Names:
  • Allegretto Wave Eye-Q 400 Hz excimer laser
  • Visx CustomVue excimer laser
  • Laser in-situ keratomileusis
  • Photorefractive keratectomy
  • Wavefront-guided
  • Wavefront-optimized
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
August 2014
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy subjects age 21 and older.
  • Subjects with nearsightedness, farsightedness and/or astigmatism.

Exclusion Criteria:Autoimmune diseases.

  • Children.
  • Women pregnant or nursing.
  • Ectatic corneal disease.
  • Previous ocular surgery.
Both
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01135719
SU-04302009-2458
No
Edward E. Manche, Stanford University
Edward E. Manche
Not Provided
Principal Investigator: Edward E. Manche Stanford University
Stanford University
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP