An interventional study of P200TE and P200TxE in Glaucoma, sponsored by Optos, PLC. Completed at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2022-09-23.
Sponsored by Optos, PLC · Not applicable, Interventional, and Diagnostic
The study evaluates the image quality between two OCT devices.
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.
1,844 studies on the registry are indexed under Glaucoma; 233 are open to participants now.
This study's enrollment of 10 is below the median of 65 across 1,296 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Optos, PLC is the lead sponsor of 18 studies on the registry; 3 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 1 (10%) have results posted.
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Exclusion Criteria:
Device: P200TE · Device: P200TxE
The P200TE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.
The P200TxE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.
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)
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
| Milestone | Optical Coherence Tomographer |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
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.
| Mean score on a scale (0-3) | Optical Coherence Tomographer - P200TE | Optical Coherence Tomographer - P200TxE |
|---|---|---|
| Average score (0-3) for clinical utility and clinical quality Indy (P200TxE) Posterior scans | — | 2.78 ± .45 |
| Average score (0-3) for clinical utility and clinical quality Indy (P200TxE) Peripheral scans | — | 2.77 ± .46 |
| Average score (0-3) for clinical utility and clinical quality Monaco (P200TE) scans | 2.08 ± .64 | — |
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.
| Participants | Optical Coherence Tomographer P200TE | Optical Coherence Tomographer - P200TxE |
|---|---|---|
| Number of Participants With Adverse Events | 0 | 0 |
Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Optical Coherence Tomographer: P200TE | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Optical Coherence Tomographer: P200TxE | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | Optical Coherence Tomographer |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 5 |
| >=65 years | 5 |
| Sex/Gender, Customized(Participants) | Optical Coherence Tomographer |
|---|---|
| Male or Female | 10 |
| Race and Ethnicity Not Collected(Participants) | Optical Coherence Tomographer |
|---|
| Region of Enrollment(participants) | Optical Coherence Tomographer |
|---|---|
| United States | 10 |
| Glaucoma in Subject eye(Participants) | Optical Coherence Tomographer |
|---|---|
| Count of participants | 10 |
Documents are hosted by the registry — open the source record to download them.
Ran from Apr 2019 to primary completion in Apr 2019, 0 months.
Results were first posted in Sep 2022, 3 years 4 months after primary completion.
Of 83 industry-sponsored interventional studies with no phase under Glaucoma, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 50. This study's 0 months is below that.
Counting every sponsor, half of 355 studies reached it within 29 months; a quarter within 15 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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