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
- 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.
- 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
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
- 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
- ClinicalTrials.gov ID
- NCT00365677
- Acronym / sponsor ID
- 441
- Conditions
- Myopia, Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 17 Aug 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zyoptix Tissue Saving Aspheric | Experimental | Device: The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithmThe Bausch \& Lomb Zyoptix Tissue Saving Aspheric algorithm is used for treatment with LASIK for the correction of myopia and myopic astigmatism. |
| Zyoptix Tissue Saving | Active comparator | Device: The Bausch & Lomb Zyoptix Tissue Saving algorithmThe Bausch \& Lomb Zyoptix Tissue Saving algorithm is used for treatment with LASIK for the 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 (3 listed)
- Myopia with or without astigmatism.
- Normal Corneal topography
- Willing to have both eyes treated with the laser.
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 |
|---|---|---|
| The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithmUsed with LASIK treatment for the correction of myopia and myopic astigmatism. | Device | Zyoptix Tissue Saving Aspheric |
| The Bausch & Lomb Zyoptix Tissue Saving algorithmUsed with LASIK treatment for the correction of myopia and myopic astigmatism. | Device | Zyoptix Tissue Saving |
Primary outcome
Uncorrected visual acuity
Time frame: At 90 days post surgery
Preservation of best spectacle corrected high contrast logMAR distance visual acuity compared to baseline.
Time frame: At 90 days post surgery
2 secondary outcomes
Deviation from target correction
Time frame: At 90 days post surgery
Improvement in uncorrected distance high contrast logMAR visual acuity compared to baseline
Time frame: At 90 days post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Joanne Egamino, PhD study director
Bausch & Lomb Incorporated
Questions about this trial
What is this clinical trial studying?
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.
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 3 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: finished, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: At 90 days post surgery). The study lists 2 primary outcomes in all. 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.