Performance and Acceptability of VSS-R

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01067716
Recruitment Status : Completed
First Posted : February 12, 2010
Results First Posted : May 22, 2013
Last Update Posted : October 31, 2013
Information provided by (Responsible Party):
Abbott Medical Optics

Brief Summary:
The results of this trial will demonstrate that AVSS software performs as intended and is acceptable in a clinical setting.

Condition or disease Intervention/treatment Phase
Refractive Error Device: STAR S4IR LASIK with VSS-R ablation profile Not Applicable

Detailed Description:
LASIK treatment across the range of myopia with or without astigmatism, hyperopia with or without astigmatism, and mixed astigmatism.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study to Evaluate the Performance and Acceptability of Advanced Variable Spot Scanning (AVSS) Ablations With the STAR S4 IR® Excimer Laser System
Study Start Date : February 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Refractive Error Device: STAR S4IR LASIK with VSS-R ablation profile
LASIK treatment targeted for emmetropia

Primary Outcome Measures :
  1. Percent of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better [ Time Frame: 1 Year ]

Other Outcome Measures:
  1. Percent Manifest Refraction Spherical Equivalent Within 1.0D [ Time Frame: 1 Year ]
    Manifest refraction spherical equivalent is the required spectacle (or glass) prescription.

  2. Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA) [ Time Frame: 1 Year ]
    After surgery, with or without best spectacle prescription the subject is not expected to see worse than before surgery. As a metric for this safety endpoint, losses of 2 lines of vision on a standard eye chart, with best spectacle correction, after surgery compared to pre-operative baseline shall be evaluated. For example 20/20 is typically considered best vision and 2 lines worse than this will be 20/32).

  3. Induced Manifest Refractive Astigmatism Greater Than 2.0 D of Absolute Cylinder Power [ Time Frame: 1 Year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female, of any race, and at least 21 years old at the time of the pre-operative examination and signing the consent form.
  • The refractive error, based on manifest refraction at the spectacle plane, of: MRSE up to -15.00 D with manifest cylinder between 0.00 and -6.00 D; MRSE up to +7.00 D, with manifest cylinder between 0.00 and 6.00 D; or Manifest cylinder (from 1.0 to 6.0 D) greater than the magnitude of sphere, and the manifest cylinder and sphere have opposite signs.
  • BSCVA of 20/20 or better.
  • UCVA of 20/40 or worse.
  • Manifest refraction sphere within ± 0.75 D of cycloplegic refraction sphere (at the same vertex distance).
  • Anticipated post-operative stromal bed thickness of at least 250 microns, based on pre-operative central corneal pachymetry minus the maximum treatment depth to be ablated and the intended flap thickness, and confirmed by intra-operative central corneal pachymetry.
  • Anticipated post-operative keratometry value (based on pre-operative manifest refraction and keratometry) that is appropriate.
  • A stable refractive error, based on an exam (or prescription) at least 12 months prior to the pre-operative examination and as compared to the pre-operative manifest refraction
  • Subjects who have worn a contact lens in the operative eye must discontinue lens wear at least three (3) consecutive weeks prior to the pre-operative examination. If, upon review of pre-operative measurements, the Investigator determines that the corneal topography is within normal limits, surgery may be scheduled (within 60 days), with no contact lens wear permitted prior to the surgery.
  • Willing and capable of returning for follow-up examinations for the duration of the study (6 months).

Exclusion Criteria:

  • Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study, as determined by verbal inquiry.
  • Concurrent use of topical or systemic medications that may impair healing, including but not limited to: antimetabolites, isotretinoin (Accutane®) within 6 months of treatment, and amiodarone hydrochloride (Cordarone®) within 12 months of treatment.
  • History of any of the following medical conditions, or any other condition that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or herpes simplex, endocrine disorders (including, but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis.
  • Subjects with a cardiac pacemaker or implanted defibrillator.
  • History of prior intraocular or corneal surgery (including cataract extraction), active ophthalmic disease or abnormality (including, but not limited to, symptomatic blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization > 1mm from limbus), retinal detachment/repair, clinically significant lens opacity, clinical evidence of trauma, corneal opacity within the central 9 mm, at risk for developing strabismus, or with evidence of glaucoma or propensity for narrow angle glaucoma.
  • Evidence of keratoconus, corneal dystrophy or irregularity, or abnormal videokeratography.
  • Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
  • Subjects with one eye that does not meet all inclusion criteria and does not fall within approved indications for treatment using the VISX® STAR S4 IR® Excimer Laser.
  • Participation in any other clinical study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01067716

Canada, British Columbia
Valley Laser Eye Centre
Abbottsford, British Columbia, Canada, V2S 3R1
Clearly LASIK
Victoria, British Columbia, Canada, V8X 1X2
Canada, Manitoba
Image Plus Laser Eye Center
Winnipeg, Manitoba, Canada, R3C 3J5
Canada, Ontario
University of Ottawa Eye Institute
Ottawa, Ontario, Canada, K1H 8LB
Yonge-Eglington Laser
Toronto, Ontario, Canada, M4P 2E5
Sponsors and Collaborators
Abbott Medical Optics
Study Director: Nicholas Tarantino, OD Abbott Medical Optics

Responsible Party: Abbott Medical Optics Identifier: NCT01067716     History of Changes
Other Study ID Numbers: STAR-107-AVSS
First Posted: February 12, 2010    Key Record Dates
Results First Posted: May 22, 2013
Last Update Posted: October 31, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases