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: July 28, 2014
Last verified: July 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: March 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
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: 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: July 28, 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 September 22, 2014