No Eye DiseaseNCT01459731
Optical Coherence Tomography (OCT) Data Collection Study
An observational study of No Eye Disease, run by Optovue at 5 sites in 2 countries.
Trial summary
Collect OCT data to evaluate the range and age trend of eye measurements. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- No Eye Disease
- How many people
- 400 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Sep 2011to Mar 2012
- 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: No eye disease
Who may be able to join
- At least 18 years of age
- Able and willing to provide consent
- Able and willing to complete the required examininations and visit
- Refractive error within 8 diopters sphere and within 2 diopters cylinder in each eye
- Best corrected visual acuity of 20/30 or better in each eye
Who cannot join
- History of leukemia, AIDS, dementia or multiple sclerosis
- Concomitant use of hydroxycloroquine or chloroquine
- Family history of glaucoma among first degree relatives
- Intraocular pressure of 22mm Hg or greater in either eye
- Unreliable or abnormal visual field
- Active ocular disease
Show all 10Show fewer
- Previously diagnosed with glaucoma or glaucoma suspect
- Congenital ocular abnormalities
- Previous intra-ocular surgery or laser treatment (other than refractive surgery or uncomplicated cataract surgery greater than 6 months previously)
- Anatomic narrow angle
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Illinois Eye Institute
Chicago, Illinois, 60616
Southern California College of Optometry
Fullerton, California, 92831
College of Optometry, Western University of Health Sciences
Pomona, California, 91766
Buena Vista Eye Care
San Jose, California, 95112
United Kingdom1 site
Institute of Ophthalmology, University College London
London, England, EC1V 9EL
About this study
Official title: Optical Coherence Tomography Data Collection Study
Collect OCT data to evaluate the range and age trend of eye measurements.
- Conditions
- No Eye Disease
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 |
|---|---|---|
| Age 18-29 | Not described | |
| Age 30-39 | Not described | |
| Age 40-49 | Not described | |
| Age 50-59 | Not described | |
| Age 60-69 | Not described | |
| Age 70+ | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
range of eye measurements
Measured: Day 1
Secondary outcomes (1)
age trend of eye measurements
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 posted26 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No Eye DiseaseStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Optovue
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George Comer, OD, MBA, Principal investigator, Southern California College of Optometry at Marshall B. Ketchum UniversityMichael Chaglasian, OD, Principal investigator, Illinois Eye InstituteJorge Cuadros, OD, PhD, Principal investigator, Buena Vista Eye CareDavid Garway-Heath, MD, Principal investigator, Institute of Ophthalmology, University College LondonPinakin G Davey, OD, PhD, Principal investigator, Western University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459731
- Sponsor's protocol ID
- OCT 200-47091
- Status last verified
- May 2012
- First submitted
- 23 Oct 2011
- Last updated
- 2 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Data Collection Study
- ClinicalTrials.gov ID
- NCT01459731
- Acronym / sponsor ID
- OCT 200-47091
- Conditions
- No Eye Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- OptovueIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 26 Oct 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.
Collect OCT data to evaluate the range and age trend of eye measurements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Age 18-29 | – | – |
| Age 30-39 | – | – |
| Age 40-49 | – | – |
| Age 50-59 | – | – |
| Age 60-69 | – | – |
| Age 70+ | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- No eye disease
Key inclusion criteria (5 listed)
- At least 18 years of age
- Able and willing to provide consent
- Able and willing to complete the required examininations and visit
- Refractive error within 8 diopters sphere and within 2 diopters cylinder in each eye
- Best corrected visual acuity of 20/30 or better in each eye
Key exclusion criteria (10 listed)
- History of leukemia, AIDS, dementia or multiple sclerosis
- Concomitant use of hydroxycloroquine or chloroquine
- Family history of glaucoma among first degree relatives
- Intraocular pressure of 22mm Hg or greater in either eye
- Unreliable or abnormal visual field
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
range of eye measurements
Time frame: Day 1
1 secondary outcome
age trend of eye measurements
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 2 May 2012.
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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.
George Comer, OD, MBA principal investigator
Southern California College of Optometry at Marshall B. Ketchum University
Michael Chaglasian, OD principal investigator
Illinois Eye Institute
Jorge Cuadros, OD, PhD principal investigator
Buena Vista Eye Care
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of No Eye Disease, run by Optovue at 5 sites in 2 countries.
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 5 inclusion and 10 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 2 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, United Kingdom. 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?
range of eye measurements (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 2 May 2012.