WaveLight® Refractive Flap Accuracy Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01941485
First received: September 10, 2013
Last updated: April 2, 2015
Last verified: April 2015
  Purpose

The purpose of this study is to evaluate the accuracy of the WaveLight FS200 femtosecond laser, as assessed by 1 day and 1 month post-operative OCT anterior segment corneal measurements compared to pre-operative flap thickness target.


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

Study Type: Interventional
Study Design: 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:
  • The Difference Between Achieved Flap Thickness at Day 1 Postoperative as Assessed by OCT and Expected Flap Thickness as Determined Pre-operatively [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The expected flap thickness as determined pre-operatively was subtracted from the achieved flap thickness at Day 1 postoperative as assessed by optical coherence tomography (ie, an imaging method using light to capture three-dimensional images).


Secondary Outcome Measures:
  • Opaque Bubble Layer (OBL) Development [ Time Frame: Day 0 (operative day) ] [ Designated as safety issue: No ]
    OBL (ie, a complication of corneal flap creation) assessed by digital photo analysis.

  • The Difference Between Achieved Flap Thickness at Month 1 Post-operative as Assessed by OCT and Expected Flap Thickness as Determined Preoperatively [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
    The expected flap thickness as determined pre-operatively subtracted from the achieved flap thickness at Month 1 postoperative as assessed by optical coherence tomography (ie, an imaging method using light to capture three-dimensional images).

  • Uncorrected Visual Acuity (UCVA) [ Time Frame: Up to Month 12 ] [ Designated as safety issue: No ]
    Visual acuity (VA) without spectacles or other visual corrective devices, assessed a distance of 4 meters and measured in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen. A lower logMAR value indicates better visual acuity.

  • Best Corrected Visual Acuity (BCVA) at Distance [ Time Frame: Up to Month 12 ] [ Designated as safety issue: No ]
    VA with the participant's best spectacles or other visual corrective devices assessed at a distance of 4 meters and measured in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen. A lower logMAR value indicates better visual acuity.

  • Manifest Refraction [ Time Frame: Up to Month 12 ] [ Designated as safety issue: No ]
    Manifest refraction as performed using visual acuity charts at a distance of 4 meters to document the sphere, cylinder and axis readings, measured in diopters.

  • Contrast Acuity [ Time Frame: Up to Month 12 ] [ Designated as safety issue: No ]
    Contrast acuity (ie, a measurement of the ability to see between different shades of gray from the background) assessed in accordance with the manufacturer's guidelines, measured in logCS. A higher logCS value indicates better contrast acuity.

  • Corneal Flap Diameter [ Time Frame: Up to Month 12 ] [ Designated as safety issue: No ]
    Diameter of the corneal flap as assessed by OCT and measured in microns.

  • Wavefront Aberrometry [ Time Frame: Up to Month 12 ] [ Designated as safety issue: No ]
    Wavefront error of the eye as measured with a commercially available system and recorded in microns.

  • Quality of Life as Reported on RSVP Questionnaire [ Time Frame: Up to Month 12 ] [ Designated as safety issue: No ]
    The Refractive Status and Vision Profile (RSVP) is a self-reported questionnaire used to measure 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 as assessed by a commercially available system and measured in diopters.

  • Flap Creation Time [ Time Frame: Day 0 (operative day) ] [ Designated as safety issue: No ]
    Treatment time with Femtosecond FS200 laser, measured in seconds.

  • Corneal Topography [ Time Frame: Up to Month 12 ] [ Designated as safety issue: No ]
    Corneal topography as assessed by a commercially available system.


Enrollment: 60
Study Start Date: October 2013
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 of care
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

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
Results First Received: February 1, 2015
Last Updated: April 2, 2015
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 July 01, 2015