Refractive ErrorNCT01067716
Performance and Acceptability of VSS-R
A study testing STAR S4IR LASIK with VSS-R ablation profile in people with Refractive Error, run by Abbott Medical Optics at 5 sites in Canada.
Trial summary
The results of this trial will demonstrate that AVSS software performs as intended and is acceptable in a clinical setting. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Refractive Error
- What is being tested?
- STAR S4IR LASIK with VSS-R ablation profile
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 5 sitesCanada
- Study dates
- Feb 2010to Mar 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Valley Laser Eye Centre
Abbottsford, British Columbia, V2S 3R1
University of Ottawa Eye Institute
Ottawa, Ontario, K1H 8LB
Yonge-Eglington Laser
Toronto, Ontario, M4P 2E5
Clearly LASIK
Victoria, British Columbia, V8X 1X2
Image Plus Laser Eye Center
Winnipeg, Manitoba, R3C 3J5
About this study
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
The results of this trial will demonstrate that AVSS software performs as intended and is acceptable in a clinical setting.
Read the detailed description
LASIK treatment across the range of myopia with or without astigmatism, hyperopia with or without astigmatism, and mixed astigmatism.
- Conditions
- Refractive Error
- Being tested
- STAR S4IR LASIK with VSS-R ablation profile
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAR S4IR LASIK with VSS-R ablation profileDevice
LASIK treatment targeted for emmetropia
| Study group | Role | What they receive |
|---|---|---|
| Refractive Error | Experimental | Not described Receives: Device: STAR S4IR LASIK with VSS-R ablation profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Refractive ErrorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Optics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicholas Tarantino, OD, Study director, Abbott Medical Optics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067716
- Sponsor's protocol ID
- STAR-107-AVSS
- Status last verified
- Oct 2013
- First submitted
- 10 Feb 2010
- Last updated
- 31 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01067716
- Acronym / sponsor ID
- STAR-107-AVSS
- Conditions
- Refractive Error
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Abbott Medical OpticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 12 Feb 2010 (estimated)
- Results
- Posted 22 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Refractive Error | Experimental | Device: STAR S4IR LASIK with VSS-R ablation profile |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STAR S4IR LASIK with VSS-R ablation profileLASIK treatment targeted for emmetropia | Device | Refractive Error |
Primary outcome
Percent of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better
Time frame: 1 Year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Refractive Error
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Clinical Performance and Outcomes After Toric Lens Transition
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Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
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A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
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Evaluation of the Agreement Between Automated Program-Operated Phoropter Subjective Refraction and Optometrist-Performed Subjective Refraction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Tarantino, OD study director
Abbott Medical Optics
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STAR S4IR LASIK with VSS-R ablation profile in people with Refractive Error, run by Abbott Medical Optics at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2013.