Use of the Visumax™ Femtosecond Laser

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Carl Zeiss Meditec, Inc.
Sponsor:
Information provided by (Responsible Party):
Carl Zeiss Meditec, Inc.
ClinicalTrials.gov Identifier:
NCT01638390
First received: July 2, 2012
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

The objective of this clinical trial is to evaluate the safety and effectiveness of the Carl Zeiss Meditec VisuMax™ Femtosecond Laser lenticule removal procedure for the reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.


Condition Intervention Phase
Myopia
Device: Treatment with the VisuMax™ Femtosecond Laser
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of the Visumax™ Femtosecond Laser Lenticule Removal Procedure for the Correction of Myopia

Further study details as provided by Carl Zeiss Meditec, Inc.:

Primary Outcome Measures:
  • Effectiveness- Predictability [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Decrease in manifest refraction spherical equivalent (MRSE) to within ± 1.00 D and ± 0.50 D of the intended refractive outcome at the point at which stability is first reached. A minimum of 75% of eyes should have an achieved refraction within ± 1.00 D of the intended outcome, and at least 50% of eyes should be within ± 0.50D of the intended outcome.

  • Effectiveness- Improvement in UCVA following treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    A minimum of 85% of eyes targeted for emmetropia should have uncorrected visual acuity of 20/40 or better at the postoperative interval at which stability has been established.

  • Stability Criteria- Three of the four stability criteria from ANSI Z80.11-2007 are required [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    At least 95% of the treated eyes should have a change ≤ 1.00 D of MRSE at the latter of two postoperative refractions performed at least 3 months apart or at 3 months after surgery when compared with the 1-month interval.

  • Stability Criteria- Three of the four stability criteria from ANSI Z80.11-2007 are required [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The mean rate of change in MRSE, as determined by paired analysis, is ≤ 0.5 D per year (0.04 D/month) over the same time period.

  • Stability Criteria- Three of the four stability criteria from ANSI Z80.11-2007 are required [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The mean rate of change of MRSE decreases monotonically over time, with a projected asymptote of zero or a rate of change attributable to normal aging.

  • Stability Criteria- Three of the four stability criteria from ANSI Z80.11-2007 are required [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The 95% confidence interval for the mean rate of change includes zero or a rate of change attributable to normal aging.

  • Safety- Preservation of Best-Spectacle Corrected Visual Acuity (BSCVA) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    1. In eyes with preoperative BSCVA 20/20 or better, < 1% worse than 20/40 at the postoperative interval at which stability has been established
    2. < 5% of eyes with BCVA loss ≥ 2 lines

  • Safety- Induced manifest refractive astigmatism [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    < 5% of eyes with > 2.00 D cylinder at the postoperative interval at which stability has been established

  • Safety- Incidence of Adverse Events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    < 1% of eyes for each type of adverse event

  • Safety- Contrast Sensitivity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Mean of "within-eye" loss of contrast sensitivity from baseline to 12 months will be provided with the 1-sided 95% confidence interval for each spatial frequency. Percentage of eyes showing ≥ 0.3 log units loss at two or more spatial frequencies will be calculated.


Secondary Outcome Measures:
  • Safety- Patient Symptoms [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Will be considered as a secondary safety variable


Estimated Enrollment: 360
Study Start Date: July 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treatment of Myopia
The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.
Device: Treatment with the VisuMax™ Femtosecond Laser
The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.
Other Name: VisuMaxTM Femtosecond Laser

Detailed Description:

This is a prospective multi-center clinical trial in which a total of 360 eyes of consecutive subjects will be enrolled, treated with the VisuMax™ Femtosecond Laser, and followed for a 12-month period. The study will be conducted at up to 8 clinical sites.

Enrollment will be phased such that 100 eyes will be initially enrolled and followed. When 50 of the initial eyes have reached the 3-month follow-up exam, an interim clinical study report will be submitted to FDA along with a request to continue enrollment up to 360 eyes.

Subjects will be screened for eligibility, and informed consent will be obtained from those who meet screening criteria and are interested in participating in the study. Eligible subjects will be examined preoperatively to obtain a medical history and to establish a baseline ocular condition. Baseline and postoperative measurements will include manifest refraction, cycloplegic refraction, distance visual acuity (best corrected and uncorrected), slit-lamp examination, fundus examination, corneal topography, central corneal pachymetry, mesopic pupil measurement, wavefront analysis, mesopic contrast sensitivity, and intraocular pressure (IOP).

  Eligibility

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and female subjects age 22 years of age and older;
  • Spherical myopia from ≥ -1.00 D to ≤ -8.00 D, with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D in the eye to be treated;
  • A stable refraction for the past year, as demonstrated by a change in MRSE of ≤ 0.50 D in the eye to be treated;
  • A difference between cycloplegic and manifest refractions of < 0.75 D spherical equivalent in the eye to be treated;
  • UCVA worse than 20/40 in the eye to be treated;
  • BSCVA at least 20/20 in the eye to be treated;
  • Discontinue use of contact lenses for at least 2 weeks (for hard lenses) or 3 days (for soft lenses) prior to the preoperative examination, and through the day of surgery;
  • All contact lens wearers must demonstrate a stable refraction (within ±0.5 D), as determined by MRSE, on two consecutive examinations at least 1 week apart, in the eye to be treated;
  • Central corneal thickness of at least 500 microns in the eye to be treated;
  • Willing and able to return for scheduled follow-up examinations;
  • Able to provide written informed consent and follow study instructions in English.

Exclusion Criteria:

  • Mesopic pupil diameter > 8.0 mm;
  • Cylinder > -0.50 D;
  • Treatment depth is less than 250 microns from the corneal endothelium;
  • Eye to be treated is targeted for monovision;
  • Fellow eye has BSCVA worse than 20/40;
  • Abnormal corneal topographic findings, e.g. keratoconus, pellucid marginal degeneration in either eye;
  • History of or current anterior segment pathology, including cataracts in the eye to be treated;
  • Clinically significant dry eye syndrome unresolved by treatment in either eye;
  • Residual, recurrent, active ocular or uncontrolled eyelid disease, corneal scars or other corneal abnormality such as recurrent corneal erosion or severe basement membrane disease in the eye to be treated;
  • Ophthalmoscopic signs of progressive or unstable myopia or keratoconus (or keratoconus suspect) in either eye;
  • Irregular or unstable (distorted/not clear) corneal mires on central keratometry images in either eye;
  • History of ocular herpes zoster or herpes simplex keratitis;
  • Deep orbits, strong blink, anxiety, pterygium, or any other finding suggesting difficulty in achieving or maintaining suction;
  • Difficulty following directions or unable to fixate;
  • Previous intraocular or corneal surgery of any kind in the eye to be treated, including any type of surgery for either refractive or therapeutic purposes;
  • History of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP > 21 mmHg in either eye;
  • History of diabetes, diagnosed autoimmune disease, connective tissue disease or clinically significant atopic syndrome;
  • Immunocompromised or requires chronic systemic corticosteroids or other immunosuppressive therapy that may affect wound healing;
  • History of known sensitivity to planned study medications;
  • Participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation;
  • Pregnant, lactating, or of child-bearing potential and not practicing a medically approved method of birth control.
  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: NCT01638390

Contacts
Contact: Aaron Ilan, Ph.D. (925) 560-5139 a.ilan@meditec.zeiss.com
Contact: Todd K. Otani, O.D. (925) 557-4513 t.otani@meditec.zeiss.com

Locations
United States, Colorado
Dishler Laser Institute Recruiting
Greenwood Village, Colorado, United States, 80111
Contact: Kelly Johnston    303-793-3000    kellyj@dishler.com   
Contact: Kim Brownfield, O.D.    (303) 793-3000    kimb@dishler.com   
Principal Investigator: Jon Dishler, M.D.         
United States, Florida
Bascom Palmer Eye Institute Recruiting
Miami, Florida, United States, 33136
Contact: Janika San Roman    305-326-6352    jsanroman@med.miami.edu   
Principal Investigator: William Culbertson, M.D.         
Principal Investigator: Sonia Yoo, M.D.         
United States, Kansas
Discover Vision Centers Recruiting
Leawood, Kansas, United States, 66211
Contact: Misty Robe    816-350-6903    mrobe@discovervision.com   
Contact: Jennifer Nelson    816-350-6936    jnelson@discovervision.com   
Principal Investigator: John Doane, M.D.         
United States, South Dakota
Vance Thompson Vision Recruiting
Sioux Falls, South Dakota, United States, 57108
Contact: Heather Oakland    605-371-7071    Heather.Oakland@vancethompsonvision.com   
Principal Investigator: Vance Thompson, M.D.         
United States, Wisconsin
Davis Duehr Dean Recruiting
Madison, Wisconsin, United States, 53717
Contact: Lynn Dombrowicki, COT    608-282-2074    lynn.dombrowicki@deancare.com   
Contact: Jacqueline Buechner, COMT    608-282-2000    Jacqueline.Buechner@deancare.com   
Principal Investigator: John Vukich, M.D.         
Sponsors and Collaborators
Carl Zeiss Meditec, Inc.
Investigators
Principal Investigator: Jon Dishler, M.D. Dishler Laser Institute
Principal Investigator: John Doane, M.D. Discover Vision Centers
Principal Investigator: Vance Thompson, M.D. Vance Thompson Vision Clinic, Prof., LLC
Principal Investigator: William Culbertson, M.D. Bascom Palmer Eye Institute
Principal Investigator: Sonia Yoo, M.D. Bascom Palmer Eye Institute
Principal Investigator: John Vukich, M.D. Davis Duehr Dean
  More Information

No publications provided

Responsible Party: Carl Zeiss Meditec, Inc.
ClinicalTrials.gov Identifier: NCT01638390     History of Changes
Other Study ID Numbers: VISUMAX-2012-1
Study First Received: July 2, 2012
Last Updated: August 1, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on July 24, 2014