Visual Outcomes and Contrast Sensitivity After Myopic LASIK

This study has been completed.
Sponsor:
Collaborator:
Alcon Laboratories
Information provided by (Responsible Party):
Daniel S. Durrie, MD, Durrie Vision
ClinicalTrials.gov Identifier:
NCT01746589
First received: December 7, 2012
Last updated: January 25, 2013
Last verified: January 2013
  Purpose

Evaluate visual outcomes and contrast sensitivity for subjects undergoing bilateral myopic LASIK procedure using the 200 kHz WaveLight® FS200 Femtosecond Laser and the WaveLight® Allegretto Wave® Eye-Q Laser. The use of advanced technology may decrease the loss of contrast sensitivity and improvement of postoperative visual acuity results.


Condition Intervention Phase
Myopia
Device: bilateral myopic LASIK
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation Of Visual Outcomes and Contrast Sensitivity After Myopic Wavefront-Optimized Lasik Using the 200 KHZ WAVELIGHT® FS200 Femtosecond Laser and the WAVELIGHT® ALLEGRETTO WAVE® EYE-Q Laser

Further study details as provided by Durrie Vision:

Primary Outcome Measures:
  • Change in Uncorrected Visual Acuity over time postoperatively [ Time Frame: Postoperatively immediate (1-3 minutes), 30 minutes, 1 hour, 2 hours, 4 hours, 1 day, and 1 month ] [ Designated as safety issue: No ]
    Change in uncorrected visual acuity from baseline, postoperatively, immediately(1-3 minutes) after surgery, 30 minutes, 1 hour, 2 hours, 4 hours, 1 day, and 1 month.


Secondary Outcome Measures:
  • Change in contrast sensitivity postoperatively as compared to baseline [ Time Frame: Postoperatively at immediately (1-3 minutes) after surgery, 30 minutes, 1 hour, 2 hours, 4 hours, 1 day and 1 month ] [ Designated as safety issue: No ]
    Contrast sensitivity (ability to distinguish between shades of gray) will be measured postoperatively immediately (1-3 minutes) after surgery, 30 minutes,1 hour, 2 hours, 4 hours, 1 day, and 1 month.


Enrollment: 22
Study Start Date: November 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
myopic LASIK procedure
All subjects will receive bilateral myopic LASIK procedure using the 200 kHz WaveLight® FS200 Femtosecond Laser and the WaveLight® Allegretto Wave® Eye-Q Laser
Device: bilateral myopic LASIK
200 kHz WaveLight® FS200 Femtosecond Laser and the WaveLight® Allegretto Wave® Eye-Q Laser
Other Name: WaveLight® Femtosecond Laser and WaveLight® Allegretto®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

INCLUSION CRITERIA

  • Male or female in good general health, 18 years of age or older at the time of the pre-operative examination
  • Patient must be able to read, comprehend and willing to give HIPPA and informed consent
  • Patient is planning to undergo a bilateral LASIK procedure
  • Both eyes must have a manifest refractive error from -1.00 D to -7.00 spherical equivalent with less than or equal to 3.00D of refractive astigmatism as expressed in spectacle minus cylinder form
  • Both eyes must have a BSCVA of 20/20 or better
  • Both eyes must demonstrate refractive stability confirmed by clinical records, previous glasses, or investigator's discretion.
  • Patient must be willing to comply with study dosing and complete the entire course of the study.

EXCLUSION CRITERIA

  • A patient with evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye
  • A patient seeking monovision
  • A patient with a known hypersensitivity to any of the components of the procedural or post-LASIK medications
  • A patient requiring the use of any ocular drop(s) and/or medication(s) in either eye during the study period with the exception of ocular drops and/or medications provided by the investigator
  • A patient having any surgical procedure within a week preceding the scheduled LASIK surgery
  • A patient with any UNCONTROLLED systemic disease (i.e., a potential patient in whom therapy for a systemic disease is not yet stabilized )
  • A patient with a history of prior intraocular or corneal surgery (including cataract extraction), active clinically significant ophthalmic disease or abnormality (including, but not limited to, blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization > 1mm from limbus), clinically significant lens opacity, clinical evidence of trauma (including scarring) inside the visual axis, or evidence of glaucoma or propensity for narrow angle glaucoma in either eye
  • A patient with a significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, may increase the risk associated with study participation or may interfere with the interpretation of study results
  • A patient with a history of any of the following medical conditions, or any other condition that could affect wound healing: uncontrolled diabetes, collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis
  • Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746589

Locations
United States, Kansas
Durrie Vision
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Daniel S. Durrie, MD
Alcon Laboratories
  More Information

No publications provided

Responsible Party: Daniel S. Durrie, MD, President, Durrie Vision
ClinicalTrials.gov Identifier: NCT01746589     History of Changes
Other Study ID Numbers: FS200SVR-10-2011
Study First Received: December 7, 2012
Last Updated: January 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Durrie Vision:
LASIK

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on September 14, 2014