Trial Outcomes & Findings for Study Comparing the P200TE and the P200TxE in Glaucoma Patients (NCT NCT03912584)
NCT ID: NCT03912584
Last Updated: 2022-09-23
Results Overview
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.
COMPLETED
NA
10 participants
1 day (start: April 29, 2019 - completed: April 30, 2019)
2022-09-23
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Optical Coherence Tomographer
n=10 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=10 Participants
|
|
Sex/Gender, Customized
Male or Female
|
10 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
|
Glaucoma in Subject eye
|
10 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Optical Coherence Tomographer - P200TE
n=10 Participants
P200TE: The P200TE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.
|
Optical Coherence Tomographer - P200TxE
n=10 Participants
P200TxE: The P200TxE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.
|
|---|---|---|
|
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 .45
|
|
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 .46
|
|
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 .64
|
—
|
SECONDARY outcome
Timeframe: 1 dayAnalysis 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.
Outcome measures
| Measure |
Optical Coherence Tomographer - P200TE
n=10 Participants
P200TE: The P200TE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.
|
Optical Coherence Tomographer - P200TxE
n=10 Participants
P200TxE: The P200TxE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
0 Participants
|
0 Participants
|
Adverse Events
Optical Coherence Tomographer: P200TE
Optical Coherence Tomographer: P200TxE
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
Restriction type: LTE60