Other Clinical Trial - Assessment of Prototype Hand-held NCT01244412

Clinical Trial Details — Status: Terminated

Study information
Verified date	May 2015
Source	University of Rochester
Contact	n/a
Is FDA regulated	No
Health authority	United States: Institutional Review Board
Study type	Observational

This is the proof of concept study to evaluate the performance of an early stage prototype of a hand-held fundus camera.

We tested a novel fundus camera. The images obtained were acceptable to move to the next step in development.

Recruitment information / eligibility
Status	Terminated
Enrollment	1
Est. completion date	December 2011
Est. primary completion date	November 2011
Accepts healthy volunteers	Accepts Healthy Volunteers
Gender	Both
Age group	18 Years and older
Eligibility	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

Observational Model: Case-Only

Locations
Country	Name	City	State
United States	Flaum Eye Institute-University of Rochester	Rochester	New York

Sponsors *(1)*
Lead Sponsor	Collaborator
University of Rochester

United States,

Outcome
Type	Measure	Description	Time frame	Safety issue
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 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	estimated 3 months	No