Clinical Trial: Correction of Myopia Wtih or Without Astigmatism Using the VisuMax™ Femtosecond Laser

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Use of the VisuMax™ Femtosecond Laser Lenticule Removal Procedure for the Correction of Myopia Wtih or Without Astigmatism

Brief Summary: 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 ≤ -10.00 D with ≤ -3.00 D cylinder (myopia with or without astigmatism) and MRSE ≤ -11.50 D.

Detailed Summary:

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

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).

Only eyes with astigmatism ≥ -0.75 D to ≤ -3.00 D targeted for the full distance manifest spherocylindrical refraction, or eye(s) with astigmatism < -0.75 D targeted for the full distance manifest sphere-only refraction, will be enrolled into the study.

Subjects must have astigmatism ≤ -3.00 D in the eye to be treated. Eyes with astigmatism ≥ -0.75 D to ≤ -3.00 D will receive a spherocylindrical treatment. Eyes with astigmatism < -0.75 D will receive a sphere-only treatment.

Operative eyes with astigmatism ≥ -0.75 D to ≤ -3.00 D must be targeted for the full distance manifest spherocylindrical refraction. Operative eye(s) with astigmatism < -0.75 D must be targeted for the full distance manifest sphere-only refraction.

Monovision treatments and retreatments
Sponsor: Carl Zeiss Meditec, Inc.

Current Primary Outcome:

  • Number of subjects with MRSE within ± 1.00 D and ± 0.50 D [ Time Frame: 1 Year ]
    Predictability: 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
  • Improvement in UCVA following treatment [ Time Frame: 1 Year ]
    The uncorrected visual acuity of 20/40 or better for eyes targeted for emmetropia at the postoperative interval at which stability has been established
  • Preservation of Best-Spectacle Corrected Visual Acuity (BSCVA) [ Time Frame: 1 Year ]

    Preservation of Best-Spectacle Corrected Visual Acuity (BSCVA):

    1. In eyes with preoperative BSCVA 20/20 or better, the percentage of eyes with BSCVA worse than 20/40 at the postoperative interval at which stability has been established
    2. The percentage of eyes with BCVA loss ≥ 2 lines
  • Number of subjects with induced MRCyl > 2.00 D [ Time Frame: 1 Year ]
    Induced manifest refractive astigmatism: The percentage of eyes treated for spherical myopia only with induced manifest refractive cylinder of > 2.00 D at the postoperative interval at which stability has been established
  • Incidence of Adverse Events [ Time Frame: 1 Year ]
    Incidence of Adverse Events: The rate of

    Original Primary Outcome: Same as current

    Current Secondary Outcome: Patient Symptoms [ Time Frame: 1 Year ]

    Patient Symptoms: Will be considered as a secondary safety variable and will be evaluated via a subject questionnaire.


    Original Secondary Outcome: Same as current

    Information By: Carl Zeiss Meditec, Inc.

    Dates:
    Date Received: April 23, 2015
    Date Started: March 2015
    Date Completion: March 2017
    Last Updated: January 30, 2017
    Last Verified: January 2017