Trial Outcomes & Findings for Low Cost OCT for Point of Care (NCT NCT03323307)
NCT ID: NCT03323307
Last Updated: 2019-12-05
Results Overview
measured by: ability to see clearly defined and recognizable structures of the retina with the low cost OCT device
COMPLETED
NA
70 participants
day 1
2019-12-05
Participant Flow
Participant milestones
| Measure |
OCT Imaging
All participants had retinal OCT imaging of both eyes. All participants were first imaged with the commercially available Heidelberg Engineering Spectralis OCT machine. All participants were then imaged with the Low Cost OCT device designed by the study team.
|
|---|---|
|
Overall Study
STARTED
|
70
|
|
Overall Study
COMPLETED
|
70
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Low Cost OCT for Point of Care
Baseline characteristics by cohort
| Measure |
OCT Imaging
n=70 Participants
All participants had retinal OCT imaging of both eyes. All participants were first imaged with the commercially available Heidelberg Engineering Spectralis OCT machine. All participants were then imaged with the Low Cost OCT device designed by the study team.
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|---|---|
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Age, Customized
<= 50 years
|
12 Participants
n=93 Participants
|
|
Age, Customized
50 - 59 years
|
6 Participants
n=93 Participants
|
|
Age, Customized
60 - 69 years
|
9 Participants
n=93 Participants
|
|
Age, Customized
70 - 79 years
|
13 Participants
n=93 Participants
|
|
Age, Customized
80 - 89 years
|
7 Participants
n=93 Participants
|
|
Age, Customized
>= 90 years
|
1 Participants
n=93 Participants
|
|
Age, Customized
Unknown or Not Reported
|
22 Participants
n=93 Participants
|
|
Sex/Gender, Customized
Male
|
29 Participants
n=93 Participants
|
|
Sex/Gender, Customized
Female
|
40 Participants
n=93 Participants
|
|
Sex/Gender, Customized
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=93 Participants
|
|
Retinal Pathology
Participants with Retinal Pathology
|
38 Participants
n=93 Participants
|
|
Retinal Pathology
Healthy Volunteers
|
32 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: day 1measured by: ability to see clearly defined and recognizable structures of the retina with the low cost OCT device
Outcome measures
| Measure |
OCT Imaging
n=70 Participants
All participants had retinal OCT imaging of both eyes. All participants were first imaged with the commercially available Heidelberg Engineering Spectralis OCT machine. All participants were then imaged with the Low Cost OCT device designed by the study team.
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|---|---|
|
Number of Participants With Acceptable OCT Image Quality
|
60 Participants
|
SECONDARY outcome
Timeframe: day 1Population: The current version of the low cost OCT device only acquired a single line image on the retina per scan, which did not allow for the pinpointing of the central macula. Therefore, central macular thickness could not be measured.
compare measurements of central macular thickness obtained with low cost OCT system and Heidelberg Spectralis OCT system
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: day 1Population: Volumetric imaging was not achievable with the current version of the low cost OCT device due to the line rate being too slow. Volumetric imaging was possible on the Heidelberg Spectralis OCT, but at a significant increase in acquisition time, which was not feasible for amount of time we had with each subject.
compare total macular volume measurements obtained with low cost OCT system and Heidelberg Spectralis OCT system
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: day 1Population: Participants from whom OCT images of acceptable quality were obtained.
Measure of OCT image quality comparing level of image contrast to level of background noise. CNR = (mean of signal of region of interest \[i.e., retina\] - mean of background noise) divided by square root of (the square of the standard deviation of the region of interest + the square of the standard deviation of the background noise). Therefore, CNR is unitless.
Outcome measures
| Measure |
OCT Imaging
n=60 Participants
All participants had retinal OCT imaging of both eyes. All participants were first imaged with the commercially available Heidelberg Engineering Spectralis OCT machine. All participants were then imaged with the Low Cost OCT device designed by the study team.
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|---|---|
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Contrast-to-Noise Ratio (CNR)
Heidelberg Spectralis OCT device
|
1.687 unitless
Standard Deviation 0.027
|
|
Contrast-to-Noise Ratio (CNR)
Low Cost OCT device
|
1.592 unitless
Standard Deviation 0.021
|
Adverse Events
OCT Imaging
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place