Performance and Acceptability of VSS-R

NCT01067716 | Completed Results

• 1 other identifier: STAR-107-AVSS
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Refractive Error

Outcome Measures

Primary Outcomes (1)

• Percent of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better

  1 Year

Other Outcomes (3)

• Percent Manifest Refraction Spherical Equivalent Within 1.0D

  1 Year

• Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)

  1 Year

• Induced Manifest Refractive Astigmatism Greater Than 2.0 D of Absolute Cylinder Power

  1 Year

Study Arms (1)

Refractive Error

EXPERIMENTAL

Device: STAR S4IR LASIK with VSS-R ablation profile

Interventions

STAR S4IR LASIK with VSS-R ablation profile DEVICE

LASIK treatment targeted for emmetropia

Refractive Error

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• Participation in any other clinical study.

Sponsors & Collaborators

• Abbott Medical Optics: lead

Study Sites (5)

Valley Laser Eye Centre

Abbottsford, British Columbia, V2S 3R1, Canada

Location

Clearly LASIK

Victoria, British Columbia, V8X 1X2, Canada

Location

Image Plus Laser Eye Center

Winnipeg, Manitoba, R3C 3J5, Canada

Location

University of Ottawa Eye Institute

Ottawa, Ontario, K1H 8LB, Canada

Location

Yonge-Eglington Laser

Toronto, Ontario, M4P 2E5, Canada

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Amelia Saliba
• Organization: Abbott Medical Optics

amelia.saliba@amo.abbott.com

408-273-4158

Study Officials

• Nicholas Tarantino, OD

  Abbott Medical Optics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2010
• First Posted: February 12, 2010
• Study Start: February 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: October 31, 2013
• Results First Posted: May 22, 2013

Record last verified: 2013-10

Locations

CA (5)