MyopiaPhase 4VBLWL-001NCT00770094
Multi Laser Platform Comparison Study for LASIK
A Phase 4 study testing Excimer Lasers, Excimer Laser for the LASIK procedure and Excimer Laser for LASIK in people with Myopia and Astigmatism, run by Durrie Vision at 3 sites in United States.
Trial summary
Comparison of LASIK outcomes using 3 different lasers and a total of 5 different treatment platforms. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia, Astigmatism
- What is being tested?
- Excimer Lasers, Excimer Laser for the LASIK procedure and Excimer Laser for LASIK
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2008to Feb 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who have up to -7.00D of spherical equivalent myopia or myopia with astigmatism, with up to -7.00D of spherical component and up to 3.00 D of astigmatic component at the spectacle plane in both eyes.
- Subjects must have a stable refraction as documented by previous clinical records or clinical history. Spherical equivalent has not progressed at a rate of more than 0.50D per year prior to the baseline examination in both eyes or as documented by clinical judgment by the investigator.
- Subjects who wear contact lenses must discontinue wear at least 3 days for soft and at least 3 weeks for RGP prior to the preoperative evaluation or surgery, in either eye.
- Subjects must have visual acuity correctable to at least 20/20 in both eyes.
- Subjects must be at least 18 years of age.
- Subjects must be willing and able to return for scheduled follow up examinations for three months after LASIK surgery.
- Subjects must sign and be given a copy of the written Informed Consent form.
Who cannot join
- Subjects for whom both eyes do not meet all inclusion criteria and either eye meets any exclusion criteria.
- Subjects for whom the combination of their baseline corneal thickness and the planned operative parameters for the LASIK procedure would result in less than 250 microns of remaining posterior corneal thickness below the flap postoperatively in either eye.
- Eyes for which the baseline standard manifest refraction exhibits greater than 1.00D more minus in sphere power, or a difference of greater than 0.75 D in cylinder power between eyes.
- Subjects desiring spherical under correction in one eye (i.e. no monovision correction is permitted).
- Subjects for whom the preoperative assessment of the ocular topography and /or aberrations indicates that either eye is not a suitable candidate for LASIK vision correction procedure. Examples include frank or forme frust keratoconus, corneal warpage, and pellucid marginal degeneration, etc.
- Subjects with clinically significant dry eye syndrome or clinically significant blepharitis in either eye.
Show all 18Show fewer
- Subjects with anterior segment pathology, including clinically significant cataracts or corneal scarring or neovascularization in either eye.
- Subjects with residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (specifically, recurrent corneal erosion, severe basement membrane disease) in either eye.
- Subjects with ophthalmoscopic signs of progressive or unstable myopia or keratoconus (or keratoconus suspect) in either eye.
- Subjects with unstable (distorted/not clear) corneal mires on central keratometry in either eye.
- Subjects who have undergone previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye.
- Subjects who have a history of Herpes zoster or Herpes simplex keratitis.
- Subjects on chronic systemic corticosteroid or other immunosuppressive therapy that may affect wound healing, any immunocompromised subjects, and subjects with clinically significant atopic disease, connective tissue disease, or diabetes.
- Subjects with a history of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP>23 mm Hg in either eye.
- Subjects with macular pathology in either eye.
- Subjects who are pregnant, lactating, or planning to be pregnant during the course of the study.
- Subjects with known sensitivity to planned study concomitant medications.
- Subjects participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Lasik Plus-Galleria
Atlanta, Georgia, 30339
Lasik Plus Edina
Edina, Minnesota, 55435
Lasik Plus-Tyson's Corner
McLean, Virginia, 22102
About this study
Official title: A Prospective, Randomized, Multi Center Clinical Comparison Of Fellow Eyes Undergoing Lasik Using The Amo/Visx Customvue™ , The Bausch And Lomb Zyoptix And Planoscan And The Wavelight Allegretto Wave™ Wavefront Guided And Wavefront Optimized Excimer Laser Systems
Comparison of LASIK outcomes using 3 different lasers and a total of 5 different treatment platforms.
Read the detailed description
This will be a prospective, randomized, multicenter clinical trial in which up to 180 consecutive eyes scheduled to undergo excimer laser in situ keratomileusis (LASIK) for the correction of myopia with or without astigmatism will be enrolled. Enrolled subjects will have a different Excimer laser system performed in each eye. There will be 30 subjects (60 eyes) in each group.
Group 1: WaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment in one eye of the subject and the AMO/VISX CustomVue™ wavefront guided Excimer Laser System performed on the contralateral eye Group 2: WaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment in one eye of the subject and the Bausch and Lomb Zyoptix™ wavefront guided Excimer Laser System performed on the contralateral eye Group 3: WaveLight ALLEGRETTO WAVE™ wavefront optimized excimer laser treatment in one eye of the subject and the Bausch and Lomb Planoscan™ Excimer Laser System performed on the contralateral eye The choice of treatment will first be randomized into one of the three groups and then will also be randomized to the dominant eye prior to LASIK procedure according to the randomization schedule
- Conditions
- Myopia, Astigmatism
- Being tested
- Excimer Lasers, Excimer Laser for the LASIK procedure, Excimer Laser for LASIK
- Keywords
- LASIK, Laser Vision correction, Myopia, Myopia with astigmatism, Nearsighted
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excimer LasersDevice
WaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment AMO/VISX CustomVue™ wavefront guided Excimer Laser System
Excimer Laser for the LASIK procedureDevice
Also called LASIK
WaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment Bausch and Lomb Zyoptix™ wavefront guided Excimer Laser System
Excimer Laser for LASIKDevice
Also called LASIK
WaveLight ALLEGRETTO WAVE™ wavefront optimized excimer laser treatment Bausch and Lomb Planoscan™ Excimer Laser System
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | WaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment in one eye of the subject and the AMO/VISX CustomVue™ wavefront guided Excimer Laser System performed on the contralateral eye Receives: Device: Excimer Lasers |
| Group 2 | Active comparator | WaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment in one eye of the subject and the Bausch and Lomb Zyoptix™ wavefront guided Excimer Laser System performed on the contralateral eye Receives: Device: Excimer Laser for the LASIK procedure |
| Group 3 | Active comparator | WaveLight ALLEGRETTO WAVE™ wavefront optimized excimer laser treatment in one eye of the subject and the Bausch and Lomb Planoscan™ Excimer Laser System performed on the contralateral eye Receives: Device: Excimer Laser for LASIK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected visual acuity
Measured: 1 month post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionFeb 2009 (estimated)
- Study completionFeb 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Durrie Vision
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00770094
- Sponsor's protocol ID
- VBLWL-001
- Acronym
- VBLWL-001
- Status last verified
- Aug 2009
- First submitted
- 8 Oct 2008
- Last updated
- 6 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multi Center Clinical Comparison Of Fellow Eyes Undergoing Lasik Using The Amo/Visx Customvue™ , The Bausch And Lomb Zyoptix And Planoscan And The Wavelight Allegretto Wave™ Wavefront Guided And Wavefront Optimized Excimer Laser Systems
- ClinicalTrials.gov ID
- NCT00770094
- Acronym / sponsor ID
- VBLWL-001 / VBLWL-001
- Conditions
- Myopia, Astigmatism
- Keywords
- LASIK, Laser Vision correction, Myopia, Myopia with astigmatism, Nearsighted
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Durrie VisionUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Oct 2008
- Primary completion
- Feb 2009 (estimated)
- Study completion
- Feb 2009 (estimated)
- First posted
- 9 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of LASIK outcomes using 3 different lasers and a total of 5 different treatment platforms.
Detailed description
This will be a prospective, randomized, multicenter clinical trial in which up to 180 consecutive eyes scheduled to undergo excimer laser in situ keratomileusis (LASIK) for the correction of myopia with or without astigmatism will be enrolled. Enrolled subjects will have a different Excimer laser system performed in each eye. There will be 30 subjects (60 eyes) in each group.
Group 1: WaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment in one eye of the subject and the AMO/VISX CustomVue™ wavefront guided Excimer Laser System performed on the contralateral eye Group 2: WaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment in one eye of the subject and the Bausch and Lomb Zyoptix™ wavefront guided Excimer Laser System performed on the contralateral eye Group 3: WaveLight ALLEGRETTO WAVE™ wavefront optimized excimer laser treatment in one eye of the subject and the Bausch and Lomb Planoscan™ Excimer Laser System performed on the contralateral eye The choice of treatment will first be randomized into one of the three groups and then will also be randomized to the dominant eye prior to LASIK procedure according to the randomization schedule
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Device: Excimer LasersWaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment in one eye of the subject and the AMO/VISX CustomVue™ wavefront guided Excimer Laser System performed on the contralateral eye |
| Group 2 | Active comparator | Device: Excimer Laser for the LASIK procedureWaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment in one eye of the subject and the Bausch and Lomb Zyoptix™ wavefront guided Excimer Laser System performed on the contralateral eye |
| Group 3 | Active comparator | Device: Excimer Laser for LASIKWaveLight ALLEGRETTO WAVE™ wavefront optimized excimer laser treatment in one eye of the subject and the Bausch and Lomb Planoscan™ Excimer Laser System performed on the contralateral eye |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects who have up to -7.00D of spherical equivalent myopia or myopia with astigmatism, with up to -7.00D of spherical component and up to 3.00 D of astigmatic component at the spectacle plane in both eyes.
- Subjects must have a stable refraction as documented by previous clinical records or clinical history. Spherical equivalent has not progressed at a rate of more than 0.50D per year prior to the baseline examination in both eyes or as documented by clinical judgment by the investigator.
- Subjects who wear contact lenses must discontinue wear at least 3 days for soft and at least 3 weeks for RGP prior to the preoperative evaluation or surgery, in either eye.
- Subjects must have visual acuity correctable to at least 20/20 in both eyes.
- Subjects must be at least 18 years of age.
Key exclusion criteria (18 listed)
- Subjects for whom both eyes do not meet all inclusion criteria and either eye meets any exclusion criteria.
- Subjects for whom the combination of their baseline corneal thickness and the planned operative parameters for the LASIK procedure would result in less than 250 microns of remaining posterior corneal thickness below the flap postoperatively in either eye.
- Eyes for which the baseline standard manifest refraction exhibits greater than 1.00D more minus in sphere power, or a difference of greater than 0.75 D in cylinder power between eyes.
- Subjects desiring spherical under correction in one eye (i.e. no monovision correction is permitted).
- Subjects for whom the preoperative assessment of the ocular topography and /or aberrations indicates that either eye is not a suitable candidate for LASIK vision correction procedure. Examples include frank or forme frust keratoconus, corneal warpage, and pellucid marginal degeneration, etc.
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 |
|---|---|---|
| Excimer LasersWaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment AMO/VISX CustomVue™ wavefront guided Excimer Laser System | Device | Group 1 |
| Excimer Laser for the LASIK procedureAlso: LASIKWaveLight ALLEGRETTO WAVE™ wavefront guided excimer laser treatment Bausch and Lomb Zyoptix™ wavefront guided Excimer Laser System | Device | Group 2 |
| Excimer Laser for LASIKAlso: LASIKWaveLight ALLEGRETTO WAVE™ wavefront optimized excimer laser treatment Bausch and Lomb Planoscan™ Excimer Laser System | Device | Group 3 |
Primary outcome
Uncorrected visual acuity
Time frame: 1 month post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Excimer Lasers, Excimer Laser for the LASIK procedure and Excimer Laser for LASIK in people with Myopia and Astigmatism, run by Durrie Vision at 3 sites in United States.
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 7 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 6 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Uncorrected visual acuity (time frame: 1 month post operative). 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 6 Aug 2009.