Visual Outcomes and Contrast Sensitivity After Myopic LASIK

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

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: bilateral myopic LASIK

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Durrie Vision

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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 Names: WaveLight® Femtosecond Laser and WaveLight® Allegretto®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Uncorrected Visual Acuity over time postoperatively	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.	Postoperatively immediate (1-3 minutes), 30 minutes, 1 hour, 2 hours, 4 hours, 1 day, and 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in contrast sensitivity postoperatively as compared to baseline	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.	Postoperatively at immediately (1-3 minutes) after surgery, 30 minutes, 1 hour, 2 hours, 4 hours, 1 day and 1 month

Collaborators and Investigators

• Sponsor: Daniel S. Durrie, MD
• Collaborators: Alcon Research

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ACTUAL): January 1, 2012
• Study Completion (ACTUAL): January 1, 2012

Study Registration Dates

• First Submitted: December 7, 2012
• First Submitted That Met QC Criteria: December 7, 2012
• First Posted (ESTIMATE): December 11, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): January 28, 2013
• Last Update Submitted That Met QC Criteria: January 25, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: LASIK
• Additional Relevant MeSH Terms: Immune System Diseases; Eye Diseases; Refractive Errors; Hypersensitivity; Myopia
• Other Study ID Numbers: FS200SVR-10-2011