WaveLight® Refractive Myopic Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01941498
First received: September 10, 2013
Last updated: February 1, 2015
Last verified: February 2015
  Purpose

The purpose of this study is to evaluate outcomes of subjects undergoing myopic surgery using the WaveLight® Refractive Suite (Excimer EX500 and Femtosecond FS200 lasers).


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 for the Evaluation of Outcomes on Subjects Undergoing Myopic Treatments Using the WaveLight® Refractive Suite

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Difference in Binocular UCVA at 1 Month Post-treatment and Pre-treatment Binocular BCVA [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
    Visual acuity (VA) with corrective devices (BCVA) was assessed binocularly (both eyes together) pre-treatment and subtracted from VA without spectacles or other visual corrective devices assessed binocularly (both eyes together) at 1 month post-treatment. VA was measured at a distance of 4 meters and measure in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen. A negative value indicates an improvement in VA from pre-treatment to Month 1.


Secondary Outcome Measures:
  • Difference Between Achieved and Target Corneal Flap Thickness as Assessed by OCT [ Time Frame: Up to Month 6 ] [ Designated as safety issue: No ]
    Thickness of the corneal flap as assessed by OCT, measured in microns.

  • Manifest Refraction [ Time Frame: Up to Month 6 ] [ 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.

  • Laser Treatment Time [ Time Frame: Day 0 (surgery) ] [ Designated as safety issue: No ]
    Treatment time with Excimer EX500 and Femtosecond FS200 lasers, measured in seconds.

  • Total Laser Treatment Time [ Time Frame: Day 0 (surgery) ] [ Designated as safety issue: No ]
    Total treatment time with Excimer EX500 and Femtosecond FS200 lasers, measured in seconds. Total duration for both eyes was calculated as sum of duration for the right eye and left eye.

  • Quality of Life as Reported on RSVP Questionnaire [ Time Frame: Up to Month 6 ] [ 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.

  • Contrast Acuity [ Time Frame: Up to Month 6 ] [ 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.

  • Wavefront Aberrometry [ Time Frame: Up to Month 6 ] [ Designated as safety issue: No ]
    Wavefront error of the eye as measured with a commercially available system and recorded in microns.

  • Corneal Curvature as Measured by Keratometry [ Time Frame: Up to Month 6 ] [ Designated as safety issue: No ]
    Corneal curvature as assessed by a commercially available system and measured in diopters.


Enrollment: 104
Study Start Date: September 2013
Study Completion Date: August 2014
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.
  • History of dry eye that is unresponsive to treatment.
  • 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: NCT01941498

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: NCT01941498     History of Changes
Other Study ID Numbers: A01353
Study First Received: September 10, 2013
Results First Received: February 1, 2015
Last Updated: February 1, 2015
Health Authority: United States: Institutional Review Board
Ireland: Research Ethics Committee
Germany: Ethics Commission

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

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on August 27, 2015