Evaluate Performance of New Fundus CameraNCT01244412
Assessment of Prototype Hand-held Fundus Camera
An observational study of Evaluate Performance of New Fundus Camera, run by University of Rochester at 1 site in United States.
Trial summary
This is the proof of concept study to evaluate the performance of an early stage prototype of a hand-held fundus camera. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Evaluate Performance of New Fundus Camera
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Dec 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: 18 years or older
Who may be able to join
- Greater than 21 years of age
- Ability to give informed consent
- Willingness to spend up to 2 hours for photos
- 5 patients presumed to be normal
- 5 patients with abnormalities of the posterior pole of the retina or the optic nerve will be studied
Who cannot join
- Any known pathology felt by the Principal Investigator to be significant so as to preclude participation as a normal subject
- Monocular subjects
- Potential subjects may be excluded based on the Principal Investigator's judgement that they are not good subjects to photograph
- Children and vulnerable subjects will not be included in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Flaum Eye Institute-University of Rochester
Rochester, New York, 14642
About this study
This is the proof of concept study to evaluate the performance of an early stage prototype of a hand-held fundus camera.
Read the detailed description
We tested a novel fundus camera. The images obtained were acceptable to move to the next step in development.
- Keywords
- Fundus photography
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Have an Acceptable Image (Image Score of 3 or Higher) of Their Eye With the Hand Held Camera
Will determine if the hand held camera is comparable to the traditional table mount camera in quality of images. The quality of the image of the participant's eye taken with the hand held camera will be compared to the quality of the image taken with the table mount camera using the following scale. We will determine the number of participants who have a score of 3 or higher.
Scale Image scored as follows
- Unacceptable: cannot see fundus detail
- Unacceptable: fundus detail visualized, but inadequate for meaningful analysis
- Acceptable: fundus detail visualized to make general comments, modest improvement image would be of sufficient quality for use
- Good: fundus detail visualized, meaningful analysis possible, std photo superior
- Excellent: fundus detail visualized as well as std photo
- Superior: fundus detail of higher quality than std photo
Measured: estimated 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionNov 2011
- Study completionDec 2011
Why it stopped: The PI wanted to make additional changes to the hand held camera therefore he terminated the study rather than continue with an outdated camera design.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Evaluate Performance of New Fundus CameraStudies 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
- Case only
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, david kleinman, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01244412
- Sponsor's protocol ID
- LUM-001
- Status last verified
- May 2015
- First submitted
- 17 Nov 2010
- Last updated
- 2 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Prototype Hand-held Fundus Camera
- ClinicalTrials.gov ID
- NCT01244412
- Acronym / sponsor ID
- LUM-001
- Keywords
- Fundus photography
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The PI wanted to make additional changes to the hand held camera therefore he terminated the study rather than continue with an outdated camera design.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 19 Nov 2010 (estimated)
- Results
- Posted 2 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is the proof of concept study to evaluate the performance of an early stage prototype of a hand-held fundus camera.
Detailed description
We tested a novel fundus camera. The images obtained were acceptable to move to the next step in development.
Study design
- Observational model
- Case only
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 18 years or older
Key inclusion criteria (5 listed)
- Greater than 21 years of age
- Ability to give informed consent
- Willingness to spend up to 2 hours for photos
- 5 patients presumed to be normal
- 5 patients with abnormalities of the posterior pole of the retina or the optic nerve will be studied
Key exclusion criteria (4 listed)
- Any known pathology felt by the Principal Investigator to be significant so as to preclude participation as a normal subject
- Monocular subjects
- Potential subjects may be excluded based on the Principal Investigator's judgement that they are not good subjects to photograph
- Children and vulnerable subjects will not be included in the study
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
Number of Participants Who Have an Acceptable Image (Image Score of 3 or Higher) of Their Eye With the Hand Held Camera
Time frame: estimated 3 months
Will determine if the hand held camera is comparable to the traditional table mount camera in quality of images. The quality of the image of the participant's eye taken with the hand held camera will be compared to the quality of the image taken with the table mount camera using the following scale. We will determine the number of participants who have a score of 3 or higher. Scale Image scored as follows 1. Unacceptable: cannot see fundus detail 2. Unacceptable: fundus detail visualized, but inadequate for meaningful analysis 3. Acceptable: fundus detail visualized to make general comments, modest improvement image would be of sufficient quality for use 4. Good: fundus detail visualized, meaningful analysis possible, std photo superior 5. Excellent: fundus detail visualized as well as std photo 6. Superior: fundus detail of higher quality than std photo
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
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 Evaluate Performance of New Fundus Camera, run by University of Rochester 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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 2 Jun 2015. 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?
Yes. Results are posted in the registry (first posted 2 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Have an Acceptable Image (Image Score of 3 or Higher) of Their Eye With the Hand Held Camera (time frame: estimated 3 months). 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 Jun 2015.