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
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