Performance and Acceptability of VSS-R

A Prospective Study to Evaluate the Performance and Acceptability of Advanced Variable Spot Scanning (AVSS) Ablations With the STAR S4 IR® Excimer Laser System

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

Study Overview

• Status: Completed
• Conditions: Refractive Error
• Intervention / Treatment: Device: STAR S4IR LASIK with VSS-R ablation profile

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Abbottsford, British Columbia, Canada, V2S 3R1
      • Valley Laser Eye Centre
    • Victoria, British Columbia, Canada, V8X 1X2
      • Clearly LASIK
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3C 3J5
      • Image Plus Laser Eye Center
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8LB
      • University of Ottawa Eye Institute
    • Toronto, Ontario, Canada, M4P 2E5
      • Yonge-Eglington Laser

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Refractive Error	Device: STAR S4IR LASIK with VSS-R ablation profile; LASIK treatment targeted for emmetropia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better	1 Year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Manifest Refraction Spherical Equivalent Within 1.0D	Manifest refraction spherical equivalent is the required spectacle (or glass) prescription.	1 Year
Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)	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).	1 Year
Induced Manifest Refractive Astigmatism Greater Than 2.0 D of Absolute Cylinder Power		1 Year

Collaborators and Investigators

• Sponsor: Abbott Medical Optics

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (ACTUAL): March 1, 2012
• Study Completion (ACTUAL): March 1, 2012

Study Registration Dates

• First Submitted: February 10, 2010
• First Submitted That Met QC Criteria: February 10, 2010
• First Posted (ESTIMATE): February 12, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): October 31, 2013
• Last Update Submitted That Met QC Criteria: October 7, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: STAR-107-AVSS