Normal and Ocular PathologyNCT01242553
Clinical Validation Study for iVue
An observational study of Normal and Ocular Pathology, run by Optovue at 2 sites in United States.
Trial summary
To demonstrate clinical substantial equivalence of iVue as comparable to commercially available RTVue. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal and Ocular Pathology
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2009to Sep 2010
- Phase
- Observational
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteers with various ocular pathology or no ocular pathology.
Who may be able to join
- Normal: Normal results from clinical exam and free of ocular pathology.
- Glaucoma: Clinical exam results consistent with glaucoma and visual field defects consistent with glaucoma.
- Cornea: Clinical exam results consistent with cornea pathology.
- Retina: Clinical exam results consistent with retina pathology
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pacific Eye Specialists
Daly City, California, 94015
Colorado Retina Center
Denver, Colorado, 80204
About this study
To demonstrate clinical substantial equivalence of iVue as comparable to commercially available RTVue.
- Conditions
- Normal and Ocular Pathology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal | Normal results from clinical exam and free of ocular pathology. | |
| Retina | Clinical exam results consistent with retina pathology | |
| Glaucoma | Clinical exam results consistent with glaucoma and visual field defects consistent with glaucoma. | |
| Cornea | Clinical exam results consistent with cornea pathology. |
What is being measured
The primary outcome is the main question the study is designed to answer.
thickness of ocular structures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2010 (estimated)
- Study startOct 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal and Ocular PathologyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optovue
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael Hee, MD, Principal investigator, Pacific Eye SpecialistsNalin Mehta, MD, Principal investigator, Colorado Retina CenterMichael Sinai, PhD, Study director, Optovue
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242553
- Sponsor's protocol ID
- iVue 100-2009
- Status last verified
- Nov 2010
- First submitted
- 15 Nov 2010
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation Study for iVue
- ClinicalTrials.gov ID
- NCT01242553
- Acronym / sponsor ID
- iVue 100-2009
- Conditions
- Normal and Ocular Pathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- OptovueIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 17 Nov 2010 (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.
To demonstrate clinical substantial equivalence of iVue as comparable to commercially available RTVue.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal | – | –Normal results from clinical exam and free of ocular pathology. |
| Retina | – | –Clinical exam results consistent with retina pathology |
| Glaucoma | – | –Clinical exam results consistent with glaucoma and visual field defects consistent with glaucoma. |
| Cornea | – | –Clinical exam results consistent with cornea pathology. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers with various ocular pathology or no ocular pathology.
Key inclusion criteria (4 listed)
- Normal: Normal results from clinical exam and free of ocular pathology.
- Glaucoma: Clinical exam results consistent with glaucoma and visual field defects consistent with glaucoma.
- Cornea: Clinical exam results consistent with cornea pathology.
- Retina: Clinical exam results consistent with retina pathology
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
thickness of ocular structures
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 28 Sep 2017.
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.
Michael Hee, MD principal investigator
Pacific Eye Specialists
Nalin Mehta, MD principal investigator
Colorado Retina Center
Michael Sinai, PhD study director
Optovue
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal and Ocular Pathology, run by Optovue at 2 sites 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 4 inclusion and 0 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 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
thickness of ocular structures. 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 28 Sep 2017; AzTrials last refreshed its copy on 26 Oct 2026.