WaveLight® Refractive Flap Accuracy Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01941485
First received: September 10, 2013
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to evaluate outcomes on subjects undergoing myopic refractive surgery using the WaveLight® Refractive Suite.


Condition Intervention
Refractive Error
Device: WaveLight® Refractive Suite
Procedure: LASIK surgery

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Global, Multi-Center Study to Evaluate Longitudinal Flap Accuracy on Subjects Undergoing Myopic Refractive Surgery Using the WaveLight® Refractive Suite

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Corneal flap thickness as assessed by ocular coherence tomography (OCT) [ Time Frame: Day 1 (post operative) ] [ Designated as safety issue: No ]
    The thickness of the corneal flap will be assessed by OCT (ie, an imaging method using light to capture three-dimensional images). Corneal flap thickness is measured in microns.


Secondary Outcome Measures:
  • Opaque bubble layer (OBL) development [ Time Frame: Day 0 (operative day) ] [ Designated as safety issue: No ]
    OBL is a complication that can occur during femtosecond flap creation. If present, OBL will be assessed at the time of surgery by digital photo analysis.

  • Corneal flap thickness as assessed by ocular coherence tomography (OCT) [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
    The thickness of the corneal flap will be assessed by OCT (ie, an imaging method using light to capture three-dimensional images). Corneal flap thickness is measured in microns.

  • Uncorrected Visual Acuity (UCVA) [ Time Frame: Up to Month 12 ] [ Designated as safety issue: No ]
    UCVA (ie, without spectacles) will be performed at a distance of four meters. UCVA is measured in logMAR (minimum angle of resolution), with a lower logMAR indicating better visual acuity.

  • Best Corrected Visual Acuity (BCVA) [ Time Frame: Up to Month 12 ] [ Designated as safety issue: No ]
    BCVA (ie, with spectacles or other visual corrective devices) will be performed at a distance of four meters. BCVA is measured in logMAR (minimum angle of resolution), with a lower logMAR indicating better visual acuity.

  • Manifest refraction per standard of care [ Time Frame: Up to Month 12 ] [ Designated as safety issue: No ]
    A series of test lenses in graded powers will be used to determine which corrective lenses provide the sharpest, clearest vision. Manifest refraction is measured in diopters.

  • Contrast Acuity [ Time Frame: Up to Month 12 ] [ Designated as safety issue: No ]
    Contrast acuity (ie, measurement of shades of gray against a background) will be assessed in accordance with the manufacturer's guidelines. Contrast acuity is measured in logMAR, with a lower logMAR indicating better contrast acuity.

  • Corneal flap diameter as assessed by ocular coherence tomography (OCT) [ Time Frame: Up to Month 12 ] [ Designated as safety issue: No ]
    The diameter of the corneal flap will be assessed by OCT (ie, an imaging method using light to capture three-dimensional images). Corneal flap diameter is measured in millimeters.

  • Total root square mean (RMS) as determined by wavefront aberrometry [ Time Frame: Up to Month 12 ] [ Designated as safety issue: No ]

    Total root square mean (RMS) as determined by wavefront aberrometry [Time Frame: Up to Month 6] [Designated as safety issue: No]

    • Wavefront aberrometry measures the eye's image-forming quality and optical abnormalities and how visual acuity is affected. Total RMS (ie, the overall magnitude of all the eye's refractive errors) will be assessed using a commercially available system. Total RMS is measured in 0.01 microns.


  • Spectacle independence as reported on the RSVP Questionnaire for Quality of Life and Retreatment [ Time Frame: Up to Month 12 ] [ Designated as safety issue: No ]
    The Refractive Status and Vision Profile (RSVP) Questionnaire measures self-reported vision-related health status in persons with refractive error.

  • Corneal curvature as measured by keratometry [ Time Frame: Up to Month 12 ] [ Designated as safety issue: No ]
    Corneal curvature will be assessed using a commercially available system. Corneal curvature is measured in diopters.

  • Flap creation time as documented in the Log Files [ Time Frame: Day 0 (operative day) ] [ Designated as safety issue: No ]
    The time to create the flap with FS200 Femtosecond Flap Creation System is measured in seconds.

  • Wavefront optimization profile (WFO) as determined by wavefront aberrometry [ Time Frame: Up to Month 12 ] [ Designated as safety issue: No ]
    Wavefront aberrometry measures the eye's image-forming quality and optical abnormalities and how visual acuity is affected. WFO profile will be assessed using a commercially available system.

  • Corneal topography [ Time Frame: Up to Month 12 ] [ Designated as safety issue: No ]
    Corneal topography (ie, variations in the front surface curvature of the cornea) will be assessed using a commercially available system.


Enrollment: 59
Study Start Date: October 2013
Estimated Study Completion Date: January 2015
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: WaveLight® Refractive Suite
LASIK surgery (laser in situ keratomileusis) per standard care of treatment and medication
Device: WaveLight® Refractive Suite
Excimer EX500 and Femtosecond FS200 lasers (Wavelight® Refractive Suite) used during LASIK surgery for corneal flap creation and corneal ablation
Procedure: LASIK surgery
Surgical procedure for treating refractive error based on corneal reshaping

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing and able to understand and sign an informed consent form.
  • Have refractive error (in both eyes) that requires refractive surgery.
  • Willing to undergo LASIK surgery using the Wavelight® Refractive Suite.
  • Myopia between 0.00 to -12.0 Diopters pre-operatively.
  • Astigmatism between 0.00 to +6.00 Diopters pre-operatively.
  • Willing and able to attend post-operative examinations per protocol schedule.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Participation in a clinical study within the last 30 days.
  • History of previous corneal surgery in either eye.
  • Multifocal ablations in either eye.
  • PRK or PTK surgery in either eye.
  • Suffering from acute or recurring eye diseases in either eye, such as corneal ulcers, cataract, etc.
  • Any ocular disease and/or condition that, in the Investigator's clinical judgment, may put subject at significant risk, compromise study results, or interfere significantly with subject's participation in the study.
  • Unable to discontinue contact lens wear as specified in protocol.
  • History of Herpes simplex or Herpes zoster keratitis.
  • Active ocular rosacea.
  • Lyme disease.
  • Severe ocular allergies.
  • Other medical conditions and use of medications as specified in protocol.
  • Pregnant or planning to become pregnant during the study.
  • Other protocol-specified exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01941485

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Stefani Smith, MS Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01941485     History of Changes
Other Study ID Numbers: A01354
Study First Received: September 10, 2013
Last Updated: February 4, 2014
Health Authority: Greece: Ethics Committee
United States: Institutional Review Board

Keywords provided by Alcon Research:
nearsighted
astigmatism
LASIK
refractive surgery
WaveLight

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 15, 2014