Performance and Acceptability of VSS-R

Refractive Error Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01067716
• Other study ID #: STAR-107-AVSS
• Status: Completed
• Phase: N/A
• First received: February 10, 2010
• Last updated: October 7, 2013
• Start date: February 2010
• Est. completion date: March 2012

Study information

• Verified date: October 2013
• Source: Abbott Medical Optics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• STAR S4IR LASIK with VSS-R ablation profile
LASIK treatment targeted for emmetropia

Locations

Country	Name	City	State
Canada	Valley Laser Eye Centre	Abbottsford	British Columbia
Canada	University of Ottawa Eye Institute	Ottawa	Ontario
Canada	Yonge-Eglington Laser	Toronto	Ontario
Canada	Clearly LASIK	Victoria	British Columbia
Canada	Image Plus Laser Eye Center	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Optics

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percent Manifest Refraction Spherical Equivalent Within 1.0D	Manifest refraction spherical equivalent is the required spectacle (or glass) prescription.	1 Year	No
Other	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	Yes
Other	Induced Manifest Refractive Astigmatism Greater Than 2.0 D of Absolute Cylinder Power		1 Year	No
Primary	Percent of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better		1 Year	No