Normal Subject PopulationNCT01899222
Assessment of Prototype Hand-Held Fundus Camera
An observational study of Normal Subject Population, run by University of Rochester at 1 site in United States.
Trial summary
Assessment of handheld fundus images in comparison to conventional fundus camera images. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Normal Subject Population
- What is being tested?
- Handheld fundus photography
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2015to 8 Oct 2015
- 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: Ophthalmology clinic
Who may be able to join
- Age > 18
- The ability to give informed consent and be willing to spend up to two hours in the eye clinic during the duration of the study.
- The subjects may have a normal retina and optic nerve, or subjects may have abnormalities of the posterior pole of the retina or the optic nerve.
Who cannot join
- Medical or ophthalmic instability that would create a contraindication for minimally invasive ophthalmic diagnostic testing will exclude participation as a subject.
- Ophthalmic pathology felt by the principal investigator that would make retinal imaging with standard photographs difficult or not possible.
Trial locations and contacts
1 site in 1 country.
About this study
Assessment of handheld fundus images in comparison to conventional fundus camera images.
Read the detailed description
This study is comparing a small handheld camera with a standard fundus camera for image quality
- Conditions
- Normal Subject Population
- Being tested
- Handheld fundus photography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handheld fundus photographyDevice
Also called imaging only
diagnostic imaging with two types of retina camera
| Study group | Role | What they receive |
|---|---|---|
| fundus imaging | retinal photograph obtained at visit Receives: Device: Handheld fundus photography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of photographs that score a "3" or higher on the grading scale
Photos will be evaluated by ophthalmologists and scored as follows:
- Unacceptable: cannot see fundus detail
- Unacceptable: fundus detail visualized, but inadequate for meaningful analysis
- Acceptable: fundus detail visualized enough to make general comments, with modest improvement image would be of sufficient quality for widespread use
- Good: fundus detail visualized, meaningful analysis possible, standard photograph superior
- Excellent: fundus detail visualized as well as standard photograph
- Superior: fundus detail of higher quality than standard photograph
Measured: 2-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study start10 Apr 2015
- Primary completion8 Oct 2015
- Study completion8 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Subject PopulationStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- 8 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
- NCT01899222
- Sponsor's protocol ID
- HHFC 02
- Status last verified
- Dec 2020
- First submitted
- 12 Jul 2013
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. 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
- NCT01899222
- Acronym / sponsor ID
- HHFC 02
- Conditions
- Normal Subject Population
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 10 Apr 2015 (actual)
- Primary completion
- 8 Oct 2015 (actual)
- Study completion
- 8 Oct 2015 (actual)
- First posted
- 15 Jul 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.
Assessment of handheld fundus images in comparison to conventional fundus camera images.
Detailed description
This study is comparing a small handheld camera with a standard fundus camera for image quality
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fundus imaging | – | Device: Handheld fundus photographyretinal photograph obtained at visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ophthalmology clinic
Key inclusion criteria (3 listed)
- Age > 18
- The ability to give informed consent and be willing to spend up to two hours in the eye clinic during the duration of the study.
- The subjects may have a normal retina and optic nerve, or subjects may have abnormalities of the posterior pole of the retina or the optic nerve.
Key exclusion criteria (2 listed)
- Medical or ophthalmic instability that would create a contraindication for minimally invasive ophthalmic diagnostic testing will exclude participation as a subject.
- Ophthalmic pathology felt by the principal investigator that would make retinal imaging with standard photographs difficult or not possible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Handheld fundus photographyAlso: imaging onlydiagnostic imaging with two types of retina camera | Device | fundus imaging |
Primary outcome
Percentage of photographs that score a "3" or higher on the grading scale
Time frame: 2-3 years
Photos will be evaluated by ophthalmologists and scored as follows: 1. Unacceptable: cannot see fundus detail 2. Unacceptable: fundus detail visualized, but inadequate for meaningful analysis 3. Acceptable: fundus detail visualized enough to make general comments, with modest improvement image would be of sufficient quality for widespread use 4. Good: fundus detail visualized, meaningful analysis possible, standard photograph superior 5. Excellent: fundus detail visualized as well as standard photograph 6. Superior: fundus detail of higher quality than standard photograph
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 9 Dec 2020.
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 Normal Subject Population, 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 3 inclusion and 2 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 9 Dec 2020. 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?
Percentage of photographs that score a "3" or higher on the grading scale (time frame: 2-3 years). 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 9 Dec 2020; AzTrials last refreshed its copy on 3 Nov 2026.