Evaluate Performance of New Fundus Camera
Conditions
Keywords
Fundus photography
Brief summary
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.
Interventions
None listed
Sponsors
University of Rochester
Study design
Observational model
CASE_ONLY
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Have an Acceptable Image (Image Score of 3 or Higher) of Their Eye With the Hand Held Camera | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Imaged Subjects | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Imaged Subjects |
|---|---|
| Acceptability of Hand Held Fundus Photograph in comparison to traditional photgraph | 1 participants |
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
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 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
Time frame: estimated 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Imaged Subjects | Number of Participants Who Have an Acceptable Image (Image Score of 3 or Higher) of Their Eye With the Hand Held Camera | 1 participants |