MyopiaNCT00365677
A Study to Investigate the Safety and Effectiveness of Aspheric Laser Refractive Surgery Treatments for Myopia
A study testing The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithm and The Bausch & Lomb Zyoptix Tissue Saving algorithm in people with Myopia and Astigmatism, run by Bausch & Lomb Incorporated.
Trial summary
The objective of this study was to compare the safety and effectiveness of two versions of the Bausch \& Lomb Zyoptix Tissue Saving Aspheric Algorithm versus the current Zyoptix Tissue Saving Algorithm when used for myopia and myopic astigmatism LASIK treatment. 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?
- The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithm and The Bausch & Lomb Zyoptix Tissue Saving algorithm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Mar 2006
- 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.
- Normal Corneal topography
- Willing to have both eyes treated with the laser.
Who cannot join
- Contraindications to LASIK.
About this study
Official title: Compare the Safety and Effectiveness of Two Versions of the Bausch & Lomb Zyoptix™ Tissue Saving Aspheric Algorithm to the Current Zyoptix™ Tissue Saving Algorithm When Used for Myopia and Myopic Astigmatism Lasik Treatment
The objective of this study was to compare the safety and effectiveness of two versions of the Bausch \& Lomb Zyoptix Tissue Saving Aspheric Algorithm versus the current Zyoptix Tissue Saving Algorithm when used for myopia and myopic astigmatism LASIK treatment.
- Conditions
- Myopia, Astigmatism
- Being tested
- The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithm, The Bausch & Lomb Zyoptix Tissue Saving algorithm
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithmDevice
Used with LASIK treatment for the correction of myopia and myopic astigmatism.
The Bausch & Lomb Zyoptix Tissue Saving algorithmDevice
Used with LASIK treatment for the correction of myopia and myopic astigmatism.
| Study group | Role | What they receive |
|---|---|---|
| Zyoptix Tissue Saving Aspheric | Experimental | The Bausch \& Lomb Zyoptix Tissue Saving Aspheric algorithm is used for treatment with LASIK for the correction of myopia and myopic astigmatism. Receives: Device: The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithm |
| Zyoptix Tissue Saving | Active comparator | The Bausch \& Lomb Zyoptix Tissue Saving algorithm is used for treatment with LASIK for the correction of myopia and myopic astigmatism. Receives: Device: The Bausch & Lomb Zyoptix Tissue Saving algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected visual acuity
Measured: At 90 days post surgery
Preservation of best spectacle corrected high contrast logMAR distance visual acuity compared to baseline.
Measured: At 90 days post surgery
Secondary outcomes (2)
Deviation from target correction
Measured: At 90 days post surgery
Improvement in uncorrected distance high contrast logMAR visual acuity compared to baseline
Measured: At 90 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2006 (estimated)
- Study startOct 2005
- Primary completionMar 2006
- Study completionMar 2006
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joanne Egamino, PhD, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365677
- Sponsor's protocol ID
- 441
- Status last verified
- Dec 2011
- First submitted
- 30 Jun 2006
- Last updated
- 8 Dec 2011
- Results posted
- No
- Data monitoring committee
- No