Clinical trial NCT01067716: Performance and Acceptability of VSS-R
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Lead sponsor: Abbott Medical Optics
Sponsor class: INDUSTRY
First posted: 2010-02-12
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Eligibility 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.

Primary outcomes:
measure: Percent of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
measure: Percent Manifest Refraction Spherical Equivalent Within 1.0D
timeFrame: 1 Year
measure: Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)
timeFrame: 1 Year
measure: Induced Manifest Refractive Astigmatism Greater Than 2.0 D of Absolute Cylinder Power
timeFrame: 1 Year
Locations:
city: Abbottsford
country: Canada
facility: Valley Laser Eye Centre
state: British Columbia
city: Victoria
country: Canada
facility: Clearly LASIK
state: British Columbia
city: Winnipeg
country: Canada
facility: Image Plus Laser Eye Center
state: Manitoba
city: Ottawa
country: Canada
facility: University of Ottawa Eye Institute
state: Ontario
city: Toronto
country: Canada
facility: Yonge-Eglington Laser
state: Ontario
Study officials:
affiliation: Abbott Medical Optics
name: Nicholas Tarantino, OD
role: STUDY_DIRECTOR
References: