HealthyNCT00347594
A Clinical Evaluation of the Next Generation Diagnostic Instrument (NGDI)
A study testing Next Generation Diagnostic Instrument (NGDI) and Zyoptix Diagnostic Workstation (ZDW) in people with Healthy, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
The purpose of this study is to measure the aberrations, corneal surface topography and pachymetry of normal human eyes with the NGDI. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Next Generation Diagnostic Instrument (NGDI) and Zyoptix Diagnostic Workstation (ZDW)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Sep 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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- +10.00D to -20.00D of absolute spherical ametropia
- Must be part of the Bausch \& Lomb research clinic
- Snellen visual acuity must be correctable to 20/25
Who cannot join
- No more than -6.00D of refractive astigmatism
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to measure the aberrations, corneal surface topography and pachymetry of normal human eyes with the NGDI.
- Conditions
- Healthy
- Being tested
- Next Generation Diagnostic Instrument (NGDI), Zyoptix Diagnostic Workstation (ZDW)
- Keywords
- Corneal surface topography, Ocular aberrations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Next Generation Diagnostic Instrument (NGDI)Device
Measurement of the aberrations, corneal surface topography, and pachymetry of normal human eyes
Zyoptix Diagnostic Workstation (ZDW)Device
Measurement of the aberrations, corneal surface topography, and pachymetry of normal human eyes
| Study group | Role | What they receive |
|---|---|---|
| Next Generation Diagnostic Instrument | Experimental | Next Generation Diagnostic Instrument (NGDI) Receives: Device: Next Generation Diagnostic Instrument (NGDI) |
| Zyoptix Diagnostic Workstation | Active comparator | Zyoptix Diagnostic Workstation (ZDW) Receives: Device: Zyoptix Diagnostic Workstation (ZDW) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of aberrations with the NGDI and the Zywave II.
Measured: Single visit
Secondary outcomes (1)
Measurement of corneal topography and pachymetry with the NGDI and the Orbscan IIz.
Measured: Single visit
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)
- Study startAug 2005
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michele Lagana, Principal investigator, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00347594
- Sponsor's protocol ID
- GVC2-03-052
- Status last verified
- Jan 2014
- First submitted
- 30 Jun 2006
- Last updated
- 17 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of the Next Generation Diagnostic Instrument (NGDI)
- ClinicalTrials.gov ID
- NCT00347594
- Acronym / sponsor ID
- GVC2-03-052
- Conditions
- Healthy
- Keywords
- Corneal surface topography, Ocular aberrations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- 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.
The purpose of this study is to measure the aberrations, corneal surface topography and pachymetry of normal human eyes with the NGDI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Next Generation Diagnostic Instrument | Experimental | Device: Next Generation Diagnostic Instrument (NGDI)Next Generation Diagnostic Instrument (NGDI) |
| Zyoptix Diagnostic Workstation | Active comparator | Device: Zyoptix Diagnostic Workstation (ZDW)Zyoptix Diagnostic Workstation (ZDW) |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- +10.00D to -20.00D of absolute spherical ametropia
- Must be part of the Bausch \& Lomb research clinic
- Snellen visual acuity must be correctable to 20/25
Key exclusion criteria (1 listed)
- No more than -6.00D of refractive astigmatism
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 |
|---|---|---|
| Next Generation Diagnostic Instrument (NGDI)Measurement of the aberrations, corneal surface topography, and pachymetry of normal human eyes | Device | Next Generation Diagnostic Instrument |
| Zyoptix Diagnostic Workstation (ZDW)Measurement of the aberrations, corneal surface topography, and pachymetry of normal human eyes | Device | Zyoptix Diagnostic Workstation |
Primary outcome
Measurement of aberrations with the NGDI and the Zywave II.
Time frame: Single visit
1 secondary outcome
Measurement of corneal topography and pachymetry with the NGDI and the Orbscan IIz.
Time frame: Single visit
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 17 Jan 2014.
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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.
Michele Lagana principal investigator
Bausch & Lomb Incorporated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Next Generation Diagnostic Instrument (NGDI) and Zyoptix Diagnostic Workstation (ZDW) in people with Healthy, run by Bausch & Lomb Incorporated at 1 site 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 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 17 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Measurement of aberrations with the NGDI and the Zywave II. (time frame: Single visit). 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 17 Jan 2014.