Optical Coherence Tomography (OCT) of the Retina
Conditions
Brief summary
The purpose of this study is to compare the performance of a prototype optical coherence tomography (OCT) machine with currently available high resolution OCT machines.
Interventions
DEVICEOCT imaging
imaging of retina using OCT device
Sponsors
University of North Carolina, Chapel Hill
Wallace H. Coulter Foundation
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients scheduled to receive standard OCT testing as part of their clinical visit
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Acceptable OCT Image Quality | day 1 | measured by: ability to see clearly defined and recognizable structures of the retina with the low cost OCT device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Central Macular Thickness | day 1 | compare measurements of central macular thickness obtained with low cost OCT system and Heidelberg Spectralis OCT system |
| Total Macular Volume | day 1 | compare total macular volume measurements obtained with low cost OCT system and Heidelberg Spectralis OCT system |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 70 |
| Total | 70 |
Baseline characteristics
| Characteristic | OCT Imaging |
|---|---|
| Age, Customized 50 - 59 years | 6 Participants |
| Age, Customized <= 50 years | 12 Participants |
| Age, Customized 60 - 69 years | 9 Participants |
| Age, Customized 70 - 79 years | 13 Participants |
| Age, Customized 80 - 89 years | 7 Participants |
| Age, Customized >= 90 years | 1 Participants |
| Age, Customized Unknown or Not Reported | 22 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 59 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants |
| Race (NIH/OMB) White | 48 Participants |
| Retinal Pathology Healthy Volunteers | 32 Participants |
| Retinal Pathology Participants with Retinal Pathology | 38 Participants |
| Sex/Gender, Customized Female | 40 Participants |
| Sex/Gender, Customized Male | 29 Participants |
| Sex/Gender, Customized Unknown or Not Reported | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 70 |
| other Total, other adverse events | 0 / 70 |
| serious Total, serious adverse events | 0 / 70 |
Outcome results
Primary
Number of Participants With Acceptable OCT Image Quality
measured by: ability to see clearly defined and recognizable structures of the retina with the low cost OCT device
Time frame: day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OCT Imaging | Number of Participants With Acceptable OCT Image Quality | 60 Participants |
Secondary
Central Macular Thickness
compare measurements of central macular thickness obtained with low cost OCT system and Heidelberg Spectralis OCT system
Time frame: day 1
Population: 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.
Secondary
Total Macular Volume
compare total macular volume measurements obtained with low cost OCT system and Heidelberg Spectralis OCT system
Time frame: day 1
Population: 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.
Post Hoc
Contrast-to-Noise Ratio (CNR)
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.
Time frame: day 1
Population: Participants from whom OCT images of acceptable quality were obtained.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OCT Imaging | Contrast-to-Noise Ratio (CNR) | Low Cost OCT device | 1.592 unitless | Standard Deviation 0.021 |
| OCT Imaging | Contrast-to-Noise Ratio (CNR) | Heidelberg Spectralis OCT device | 1.687 unitless | Standard Deviation 0.027 |