MyopiaNCT00347997
A Study to Evaluate the Safety and Effectiveness of the 217z Laser With Zyoptix for Lasik
A study testing 217z Laser in people with Myopia and Astigmatism, run by Bausch & Lomb Incorporated.
Trial summary
A Study to demonstrate the safety and efficacy of wavefront laser refractive surgery treatments for myopia and astigmatism. 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?
- 217z Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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
- Myopia with or without astigmatism.
Who cannot join
- Contraindications to LASIK.
About this study
A Study to demonstrate the safety and efficacy of wavefront laser refractive surgery treatments for myopia and astigmatism.
- Conditions
- Myopia, Astigmatism
- Being tested
- 217z Laser
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
217z LaserDevice
LASIK correction of myopia and myopic astigmatism
| Study group | Role | What they receive |
|---|---|---|
| LASIK | Experimental | LASIK correction of myopia and myopic astigmatism Receives: Device: 217z Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
Why it stopped: Decision made by B\&L to cancel the study, no subjects enrolled.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohinder Merchea, OD, PhD, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00347997
- Sponsor's protocol ID
- 385
- Status last verified
- Dec 2011
- First submitted
- 30 Jun 2006
- Last updated
- 8 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Effectiveness of the 217z Laser With Zyoptix for Lasik
- ClinicalTrials.gov ID
- NCT00347997
- Acronym / sponsor ID
- 385
- Conditions
- Myopia, Astigmatism
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Decision made by B\&L to cancel the study, no subjects enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- First posted
- 4 Jul 2006 (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.
A Study to demonstrate the safety and efficacy of wavefront laser refractive surgery treatments for myopia and astigmatism.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LASIK | Experimental | Device: 217z LaserLASIK correction of myopia and myopic astigmatism |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Myopia with or without astigmatism.
Key exclusion criteria (1 listed)
- Contraindications to LASIK.
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 |
|---|---|---|
| 217z LaserLASIK correction of myopia and myopic astigmatism | Device | LASIK |
Primary outcome
Visual acuity
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2011.
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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.
Mohinder Merchea, OD, PhD study director
Bausch & Lomb Incorporated
Questions about this trial
What is this clinical trial studying?
A study testing 217z Laser in people with Myopia and Astigmatism, run by Bausch & Lomb Incorporated.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 8 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Visual acuity (time frame: 24 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 8 Dec 2011.