Performance and Acceptability of VSS-R

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT01067716
First received: February 10, 2010
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention
Refractive Error
Device: STAR S4IR LASIK with VSS-R ablation profile

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Abbott Medical Optics:

Primary Outcome Measures:
  • Percent of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Percent Manifest Refraction Spherical Equivalent Within 1.0D [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Manifest refraction spherical equivalent is the required spectacle (or glass) prescription.

  • Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA) [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
    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).

  • Induced Manifest Refractive Astigmatism Greater Than 2.0 D of Absolute Cylinder Power [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: February 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Refractive Error Device: STAR S4IR LASIK with VSS-R ablation profile
LASIK treatment targeted for emmetropia

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01067716

Locations
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
Investigators
Study Director: Nicholas Tarantino, OD Abbott Medical Optics
  More Information

No publications provided

Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT01067716     History of Changes
Other Study ID Numbers: STAR-107-AVSS
Study First Received: February 10, 2010
Results First Received: March 28, 2013
Last Updated: October 7, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on July 23, 2014