Trial Outcomes & Findings for Topcon 3D OCT-1000 Optical Coherence Tomography System (NCT NCT00792259)
NCT ID: NCT00792259
Last Updated: 2022-06-28
Results Overview
The precision and agreement measures the thickness of RNFL and Full Retinal Thickness of the study device and is compared to the predicate device to show agreement. Keywords, ILM - Internal Limiting Membrane RPE - Retinal Pigment Epithelium RNFL - Retinal Nerve Fiber Layer
Recruitment status
COMPLETED
Target enrollment
48 participants
Primary outcome timeframe
30 Minutes
Results posted on
2022-06-28
Participant Flow
Participant milestones
| Measure |
Retinal Disease Eyes
Retinal Disease subjects with ocular pathology
|
Normal Subjects
Normal subjects with no known ocular pathology
|
Glaucoma Subjects
Subjects presented with Glaucoma
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
20
|
13
|
|
Overall Study
COMPLETED
|
14
|
20
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Retinal Disease Eyes
Retinal Disease subjects with ocular pathology
|
Normal Subjects
Normal subjects with no known ocular pathology
|
Glaucoma Subjects
Subjects presented with Glaucoma
|
|---|---|---|---|
|
Overall Study
Poor Quality Scans
|
1
|
0
|
0
|
Baseline Characteristics
Topcon 3D OCT-1000 Optical Coherence Tomography System
Baseline characteristics by cohort
| Measure |
Normal Subjects
n=20 Participants
Normal Subjects with no known ocular pathology
|
Retinal Disease Subjects
n=15 Participants
Retinal Disease subjects with ocular pathology
|
Glaucoma Subjects
n=13 Participants
Glaucoma subjects presented with pathology
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Age, Continuous
|
33.45 years
STANDARD_DEVIATION 10.36 • n=5 Participants
|
66.6 years
STANDARD_DEVIATION 13.92 • n=7 Participants
|
59.1 years
STANDARD_DEVIATION 17.63 • n=5 Participants
|
50.52 years
STANDARD_DEVIATION 20.05 • n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
15 participants
n=7 Participants
|
13 participants
n=5 Participants
|
48 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 30 MinutesThe precision and agreement measures the thickness of RNFL and Full Retinal Thickness of the study device and is compared to the predicate device to show agreement. Keywords, ILM - Internal Limiting Membrane RPE - Retinal Pigment Epithelium RNFL - Retinal Nerve Fiber Layer
Outcome measures
| Measure |
Normal Subjects
n=20 Participants
Normal subjects with no known ocular pathology
|
Retinal Disease Eyes
n=15 Participants
Retinal Disease subjects with ocular pathology
|
Glaucoma Subjects
n=13 Participants
Subjects presented with glaucoma
|
|---|---|---|---|
|
Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device
RNFL Thickness 3D OCT-1000
|
107.4 µm
Standard Deviation 10.50
|
NA µm
Standard Deviation NA
Subject group not observed for this measurement
|
70.7 µm
Standard Deviation 19.87
|
|
Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device
RNFL Thickness Stratus
|
105.9 µm
Standard Deviation 9.98
|
NA µm
Standard Deviation NA
Subject group not observed for this measurement
|
72.1 µm
Standard Deviation 20.25
|
|
Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device
Retinal Thickness ILM-IS/OS 3D OCT-1000
|
235.0 µm
Standard Deviation 9.03
|
236.1 µm
Standard Deviation 48.06
|
NA µm
Standard Deviation NA
Subject group not observed for this measurement
|
|
Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device
Retinal Thickness ILM-IS/OS Stratus
|
236.0 µm
Standard Deviation 12.54
|
263.1 µm
Standard Deviation 48.66
|
NA µm
Standard Deviation NA
Subject group not observed for this measurement
|
|
Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device
Retinal Thickness ILM-RPE 3D OCT-1000
|
252.8 µm
Standard Deviation 7.68
|
279.5 µm
Standard Deviation 45.36
|
NA µm
Standard Deviation NA
Subject group not observed for this measurement
|
|
Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device
Retinal Thickness ILM-BM 3D OCT-1000
|
296.0 µm
Standard Deviation 8.97
|
318.5 µm
Standard Deviation 41.90
|
NA µm
Standard Deviation NA
Subject group not observed for this measurement
|
Adverse Events
Retinal Disease Eyes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Glaucoma Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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