Trial Outcomes & Findings for Assessment of Prototype Hand-held Fundus Camera (NCT NCT01244412)

Results Overview

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

Recruitment status

TERMINATED

Target enrollment

1 participants

Primary outcome timeframe

estimated 3 months

Results posted on

2015-06-02

Participant Flow

Participant milestones

Participant milestones
Measure	Imaged Subjects Subjects imaged with hand held device
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of Prototype Hand-held Fundus Camera

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Imaged Subjects n=1 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants
Acceptability of Hand Held Fundus Photograph in comparison to traditional photgraph	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Imaged Subjects n=1 Participants
Number of Participants Who Have an Acceptable Image (Image Score of 3 or Higher) of Their Eye With the Hand Held Camera	1 participants

Adverse Events

Imaged Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Kleinman, MD

University of Rochester

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60