HealthyNCT01370850
Clinical Validation Study of RTVue Features
An observational study of Healthy and Glaucoma, run by Optovue at 1 site in United States.
Trial summary
To perform a clinical validation study of RTVue features in volunteers with various ocular pathology or no ocular pathology. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Apr 2011
- 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 years and older
- 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 subjects will have normal results from the clinical exam and be free of ocular pathology.
- Glaucoma patients will have clinical exam results consistent with glaucoma; they will have visual field defects consistent with glaucoma and/or structural damage consistent with glaucoma.
- Retina patients will have clinical exam results consistent with retina pathology.
Who cannot join
- Normal subjects will be free of any ocular pathology.
- Glaucoma patients will be free of any ocular pathology except glaucoma.
- Retina patients will be free of any ocular pathology except any type of retina pathology.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pacific Eye Specialists
Daly City, California, 94015
About this study
To perform a clinical validation study of RTVue features in volunteers with various ocular pathology or no ocular pathology.
Read the detailed description
Clinical validation study of RTVue features in volunteers with various ocular pathology or no ocular pathology. Subjects to undergo a clinical exam and OCT scanning.
- Keywords
- Retina pathology
- Medical subject headings
- Glaucoma
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 the clinical exam and free of ocular pathology. | |
| Glaucoma | Clinical exam results consistent with glaucoma; visual field defects consistent with glaucoma and/or structural damage consistent with glaucoma. | |
| Retina | Clinical exam results consistent with retina pathology. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retina measurement
Measured: at time of study visit (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2011
- Study completionApr 2011
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optovue
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mike Sinai, PhD, Study director, Optovue
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370850
- Sponsor's protocol ID
- RTVue Validation Study
- Status last verified
- Jun 2011
- First submitted
- 28 Apr 2011
- Last updated
- 10 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation Study of RTVue Features
- ClinicalTrials.gov ID
- NCT01370850
- Acronym / sponsor ID
- RTVue Validation Study
- Keywords
- Retina pathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- OptovueIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 10 Jun 2011 (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 perform a clinical validation study of RTVue features in volunteers with various ocular pathology or no ocular pathology.
Detailed description
Clinical validation study of RTVue features in volunteers with various ocular pathology or no ocular pathology. Subjects to undergo a clinical exam and OCT scanning.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal | – | –Normal results from the clinical exam and free of ocular pathology. |
| Glaucoma | – | –Clinical exam results consistent with glaucoma; visual field defects consistent with glaucoma and/or structural damage consistent with glaucoma. |
| Retina | – | –Clinical exam results consistent with retina pathology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers with various ocular pathology or no ocular pathology
Key inclusion criteria (3 listed)
- Normal subjects will have normal results from the clinical exam and be free of ocular pathology.
- Glaucoma patients will have clinical exam results consistent with glaucoma; they will have visual field defects consistent with glaucoma and/or structural damage consistent with glaucoma.
- Retina patients will have clinical exam results consistent with retina pathology.
Key exclusion criteria (3 listed)
- Normal subjects will be free of any ocular pathology.
- Glaucoma patients will be free of any ocular pathology except glaucoma.
- Retina patients will be free of any ocular pathology except any type of retina pathology.
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
Retina measurement
Time frame: at time of study visit (day 1)
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 10 Jun 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.
Mike Sinai, PhD study director
Optovue
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Glaucoma, run by Optovue 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 3 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 10 Jun 2011. 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?
Retina measurement (time frame: at time of study visit (day 1)). 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 10 Jun 2011.