Glaucoma
Conditions
Brief summary
The study evaluates the image quality between two OCT devices.
Detailed description
The objective of this study is to collect OCT scans to compare the qualitative B scan images produced by the P200TxE to the P200TE device in glaucoma subjects.
Interventions
DEVICEP200TE
The P200TE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.
DEVICEP200TxE
The P200TxE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.
Sponsors
Optos, PLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subjects 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed; * Subjects who can follow the instructions by the clinical staff at the clinical site, * Subjects who agree to participate in the study; * Subjects who have been diagnosed with glaucoma in the study eye as confirmed by the investigator;
Exclusion criteria
* Subjects unable to tolerate ophthalmic imaging; * Subjects with ocular media not sufficiently clear to obtain acceptable OCT images; * Subjects with any clinically significant ocular pathology except glaucoma, as determined by self-report and/or investigator assessment on the day of the study visit; * Subjects who are not reliably tested with at least one Humphrey Field Analyzer (HFA) visual field (24-2 or 30-2, white on white) measured on the day of the study visit or within the previous year from the study visit, defined as fixation losses \> 20% or false positives \> 33%, or false negatives \> 33%; * Subjects with history of dementia or multiple sclerosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative B-Scan Assessment | 1 day (start: April 29, 2019 - completed: April 30, 2019) | Scores will be based on a 4 point grading scale (0 to 3), with 0 corresponding to failure, 1 is poor, 2 is fair, and 3 is good. The four point scale is defined as follows: 0 indicates the scan is a failure, and contains no clinically useful information. No relevant structures are visible in the scan. 1. indicates the condition of the structure or feature being assessed is poor, and it contains very limited clinical utility. 2. indicates the condition of the structure or feature being assessed is fair or average. It contains some useful clinical information and therefore provides adequate clinical utility. 3. indicates the condition of the structure or feature being assessed is good. It contains useful clinical information. The clinical utility is high or good. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 1 day | Analysis of safety will be assessed through adverse events reported by the site and documented on each subject's case report form. No AEs were recorded during this study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Optical Coherence Tomographer P200TE: The P200TE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.
P200TxE: The P200TxE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Optical Coherence Tomographer | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 5 Participants | — |
| Age, Categorical Between 18 and 65 years | 5 Participants | — |
| Glaucoma in Subject eye | 10 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 10 participants | — |
| Sex/Gender, Customized Male or Female | 10 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Qualitative B-Scan Assessment
Scores will be based on a 4 point grading scale (0 to 3), with 0 corresponding to failure, 1 is poor, 2 is fair, and 3 is good. The four point scale is defined as follows: 0 indicates the scan is a failure, and contains no clinically useful information. No relevant structures are visible in the scan. 1. indicates the condition of the structure or feature being assessed is poor, and it contains very limited clinical utility. 2. indicates the condition of the structure or feature being assessed is fair or average. It contains some useful clinical information and therefore provides adequate clinical utility. 3. indicates the condition of the structure or feature being assessed is good. It contains useful clinical information. The clinical utility is high or good.
Time frame: 1 day (start: April 29, 2019 - completed: April 30, 2019)
Population: The average score (0-3) for clinical utility and clinical quality for the P200TxE does not apply to P200TE scans, and the average score (0-3) for clinical utility and clinical quality for the P200TE does not apply to P200TxE scans. 10 subjects were imaged in total, however clinical utility and quality were measured separately for the three outcomes described below (1. Indy posterior scans, 2. Indy peripheral scans, 3. Monaco scans).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Optical Coherence Tomographer - P200TE | Qualitative B-Scan Assessment | Average score (0-3) for clinical utility and clinical quality Monaco (P200TE) scans | 2.08 Mean score on a scale (0-3) | Standard Deviation 0.64 |
| Optical Coherence Tomographer - P200TxE | Qualitative B-Scan Assessment | Average score (0-3) for clinical utility and clinical quality Indy (P200TxE) Posterior scans | 2.78 Mean score on a scale (0-3) | Standard Deviation 0.45 |
| Optical Coherence Tomographer - P200TxE | Qualitative B-Scan Assessment | Average score (0-3) for clinical utility and clinical quality Indy (P200TxE) Peripheral scans | 2.77 Mean score on a scale (0-3) | Standard Deviation 0.46 |
Secondary
Number of Participants With Adverse Events
Analysis of safety will be assessed through adverse events reported by the site and documented on each subject's case report form. No AEs were recorded during this study.
Time frame: 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Optical Coherence Tomographer - P200TE | Number of Participants With Adverse Events | 0 Participants |
| Optical Coherence Tomographer - P200TxE | Number of Participants With Adverse Events | 0 Participants |