Assessment of Prototype Hand-held Fundus Camera
This study has been terminated.
(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to make additional changes to the hand held camera therefore he terminated the study rather than continue with an outdated camera design.)
Information provided by (Responsible Party):
david kleinman, University of Rochester
First received: November 17, 2010
Last updated: May 15, 2015
Last verified: May 2015
This is the proof of concept study to evaluate the performance of an early stage prototype of a hand-held fundus camera.
Evaluate Performance of New Fundus Camera
||Observational Model: Case-Only
||Assessment of Prototype Hand-held Fundus Camera
Primary Outcome Measures:
- 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
- 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
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2011 (Final data collection date for primary outcome measure)
We tested a novel fundus camera. The images obtained were acceptable to move to the next step in development.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
18 years or older
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244412
|Flaum Eye Institute-University of Rochester
|Rochester, New York, United States, 14642 |
University of Rochester
||david kleinman, Medical Doctor, University of Rochester
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 17, 2010
|Results First Received:
||June 5, 2013
||May 15, 2015
Keywords provided by david kleinman, University of Rochester:
ClinicalTrials.gov processed this record on July 21, 2017