Refractive ErrorNCT01220466
Performance and Acceptability of iDesign
A study testing STAR S4IR LASIK with iDesign Aberrometer in people with Refractive Error, run by Abbott Medical Optics at 4 sites in Canada.
Trial summary
The results of this trial will demonstrate that the iDesign System performs as intended and is acceptable in a clinical setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractive Error
- What is being tested?
- STAR S4IR LASIK with iDesign Aberrometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 4 sitesCanada
- Study dates
- Oct 2010to Dec 2011
- 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 18 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 18 years old at the time the consent form is signed.
- The refractive error, based on manifest refraction (adjusted for optical infinity), must be MRSE up to -15.00 D with manifest cylinder between 0.00 and -6.00 D; MRSE up to +9.00 D with cylinder between 0.00 and +6.00 D; or manifest cylinder (from 1.00 to 6.00 D) greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
- BSCVA of 20/20 or better.
- UCVA:
- Myopes must be 20/40 or worse.
- Subjects with Hyperopia or mixed astigmatism, treatment may be based on difficulty maintaining UCVA of 20/40 evidenced by spectacle/contact lens dependence for distance, as documented by the investigator.
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- Wavefront diameter ≥ 4.0 mm.
- Sufficient agreement between manifest refraction (adjusted for optical infinity) and iDesign System refraction (sphere, cylinder, and axis) to allow treatment selection and generation of an ablation profile as determined by the investigational iDesign System software.
- Manifest refraction sphere within ± 0.75 D of cycloplegic refraction sphere.
- 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 (as calculated by the iDesign System) and the intended flap thickness.
- Anticipated post-operative keratometry value (based on pre-operative iDesign System refraction and keratometry) that is appropriate.
- A stable refractive error (based on a previous exam, medical records, or prescription) as compared to the unadjusted pre-operative manifest refraction.
- Subjects who currently wear contact lenses must demonstrate refractive stability in the operative eye. Rigid or toric lenses must be removed for at least 2 weeks and SCL for at least 3 days prior to the first refraction used to establish stability. A second refraction with a change of no more than ± 0.50 D MRSE at least 7 days after baseline.
- Willing and capable of returning for follow-up examinations for the duration of the study.
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, or another condition associated with the fluctuation of hormones that could lead to refractive changes.
- Subjects with an ametropic or amblyopic fellow eye not meeting all inclusion criteria that does not fall within the indications for treatment using the VISX® STAR S4 IR™ Excimer Laser.
- Concurrent use of systemic (including inhaled) medications that may impair healing, including but not limited to: steroids, antimetabolites, isotretinoin (Accutane™) within 6 months of treatment, and amiodarone hydrochloride (Cordarone™) within 12 months of treatment.
- Acute or chronic disease, illness, or treatment that would increase the operative risk (e.g., immuno-compromised, autoimmune disease, connective tissue disease, clinically significant atopic disease, diabetes, etc.).
- Subjects with a cardiac pacemaker, implanted defibrillator, implanted neurostimulator, or any active electrical implants.
- Ocular condition (other than high myopia) that may predispose the subject to future complications, such as history or evidence of active or inactive corneal disease
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- Previous intraocular or corneal surgery that might confound the outcome of the study or increase risk to the subject.
- Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
- Concurrent participation in any other clinical study.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
University of Ottawa Eye Institute, The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
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 the iDesign Advanced WaveScan Study(tm) System
The results of this trial will demonstrate that the iDesign System 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 iDesign Aberrometer
- 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 iDesign AberrometerDevice
Also called CustomVue
CustomVue LASIK targeted for emmetropia
| Study group | Role | What they receive |
|---|---|---|
| Refractive Error | Experimental | Not described Receives: Device: STAR S4IR LASIK with iDesign Aberrometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2011
- Study completionDec 2011
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
- 77 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
- NCT01220466
- Sponsor's protocol ID
- STAR-108-IDSN
- Status last verified
- May 2013
- First submitted
- 24 Sep 2010
- Last updated
- 20 May 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 20 May 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 the iDesign Advanced WaveScan Study(tm) System
- ClinicalTrials.gov ID
- NCT01220466
- Acronym / sponsor ID
- STAR-108-IDSN
- Conditions
- Refractive Error
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Abbott Medical OpticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 14 Oct 2010 (estimated)
- Results
- Posted 20 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 the iDesign System 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 iDesign Aberrometer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female, of any race, and at least 18 years old at the time the consent form is signed.
- The refractive error, based on manifest refraction (adjusted for optical infinity), must be MRSE up to -15.00 D with manifest cylinder between 0.00 and -6.00 D; MRSE up to +9.00 D with cylinder between 0.00 and +6.00 D; or manifest cylinder (from 1.00 to 6.00 D) greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
- BSCVA of 20/20 or better.
- UCVA:
- Wavefront diameter ≥ 4.0 mm.
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, or another condition associated with the fluctuation of hormones that could lead to refractive changes.
- Subjects with an ametropic or amblyopic fellow eye not meeting all inclusion criteria that does not fall within the indications for treatment using the VISX® STAR S4 IR™ Excimer Laser.
- Concurrent use of systemic (including inhaled) medications that may impair healing, including but not limited to: steroids, antimetabolites, isotretinoin (Accutane™) within 6 months of treatment, and amiodarone hydrochloride (Cordarone™) within 12 months of treatment.
- Acute or chronic disease, illness, or treatment that would increase the operative risk (e.g., immuno-compromised, autoimmune disease, connective tissue disease, clinically significant atopic disease, diabetes, etc.).
- Subjects with a cardiac pacemaker, implanted defibrillator, implanted neurostimulator, or any active electrical implants.
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 iDesign AberrometerAlso: CustomVueCustomVue LASIK targeted for emmetropia | Device | Refractive Error |
Primary outcome
Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better.
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
4 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 iDesign Aberrometer in people with Refractive Error, run by Abbott Medical Optics at 4 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 14 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 20 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 20 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?
Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better. (time frame: 6 months). 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 20 May 2013.