Assess Eye Measurements in Patients Having Retina Pathology or GlaucomaNCT01806402
Evaluation of OCT Measurements
An observational study of Assess Eye Measurements in Patients Having Retina Pathology or Glaucoma, run by Optovue at 3 sites in United States.
Trial summary
The purpose of the study is to repeatability, reproducibility and agreement of eye measurements in retina and glaucoma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Assess Eye Measurements in Patients Having Retina Pathology or Glaucoma
- How many people
- 135 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2013to Aug 2013
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients will have retina pathology or glaucoma.
Who may be able to join
- At least 18 years of age
- Able and willing to provide consent
- Willing to complete the required examinations and visits
- Best corrected visual acuity equal or better than 20/100
- Retina subject must have clinical diagnosis of retinal pathology
- Glaucoma subjects must have clinical diagnosis of glaucoma
Who cannot join
- Unable to complete the required examinations and visits
- Poor OCT image quality as a result of media opacity, extreme refractive error or pathologies in the anterior segment
- Confounding pathology requiring surgical treatment or medical intervention
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pacific Eye Specialists
Daly City, California, 94015
North Bay Eye Associates
Petaluma, California, 94954
West Coast Retinal Medical Group
Walnut Creek, California, 94596
About this study
Official title: Evaluation of the Precision and Accuracy of OCT Measurements in Retinal and Glaucoma Patients
The purpose of the study is to repeatability, reproducibility and agreement of eye measurements in retina and glaucoma patients.
Read the detailed description
The purpose of the study is to repeatability, reproducibility and agreement of eye measurements in retina and glaucoma patients using OCT technology. There will be a series of measurements acquired from one eye on at least 2 different OCT devices. All testing will be completed in one visit.
- 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 |
|---|---|---|
| Retina | Having clinical diagnosis of retina pathology | |
| Glaucoma | Having clinical diagnosis of glaucoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retina thickness
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assess Eye Measurements in Patients Having Retina Pathology or GlaucomaStudies 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
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optovue
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806402
- Sponsor's protocol ID
- 20130104
- Status last verified
- Jan 2014
- First submitted
- 5 Mar 2013
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Precision and Accuracy of OCT Measurements in Retinal and Glaucoma Patients
- ClinicalTrials.gov ID
- NCT01806402
- Acronym / sponsor ID
- 20130104
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- OptovueIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 7 Mar 2013 (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 the study is to repeatability, reproducibility and agreement of eye measurements in retina and glaucoma patients.
Detailed description
The purpose of the study is to repeatability, reproducibility and agreement of eye measurements in retina and glaucoma patients using OCT technology. There will be a series of measurements acquired from one eye on at least 2 different OCT devices. All testing will be completed in one visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retina | – | –Having clinical diagnosis of retina pathology |
| Glaucoma | – | –Having clinical diagnosis of glaucoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will have retina pathology or glaucoma.
Key inclusion criteria (6 listed)
- At least 18 years of age
- Able and willing to provide consent
- Willing to complete the required examinations and visits
- Best corrected visual acuity equal or better than 20/100
- Retina subject must have clinical diagnosis of retinal pathology
Key exclusion criteria (3 listed)
- Unable to complete the required examinations and visits
- Poor OCT image quality as a result of media opacity, extreme refractive error or pathologies in the anterior segment
- Confounding pathology requiring surgical treatment or medical intervention
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 thickness
Time frame: 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 22 Jan 2014.
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Assess Eye Measurements in Patients Having Retina Pathology or Glaucoma, run by Optovue at 3 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 6 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 22 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 3 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?
Retina thickness (time frame: 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 22 Jan 2014.