Trial Outcomes & Findings for TopQ Cut-off Score Validation Study for 3D OCT-1 Maestro (NCT NCT02447133)
NCT ID: NCT02447133
Last Updated: 2022-06-29
Results Overview
To validate the values of the predetermined TopQ score by showing the variability above and below the TopQ score of 25 for 12x9 Wide, 28 for 6x6 Macula, and 30 for 6x6 Disc scans.
Recruitment status
COMPLETED
Target enrollment
12 participants
Primary outcome timeframe
1 hour
Results posted on
2022-06-29
Participant Flow
Participant milestones
| Measure |
Subjects Presenting With Normal Eyes
Subjects with no known ocular diseases will be scanned on the Maestro device
3D OCT-1 Maestro: OCT Machine used for diagnostic purposes
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TopQ Cut-off Score Validation Study for 3D OCT-1 Maestro
Baseline characteristics by cohort
| Measure |
Subjects Presenting With Normal Eyes
n=12 Participants
Subjects with no known ocular diseases will be scanned on the Maestro device
3D OCT-1 Maestro: OCT Machine used for diagnostic purposes
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age, Continuous
|
43.17 years
STANDARD_DEVIATION 13.48 • n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 hourPopulation: use of 12 subjects for 3 different scan patterns
To validate the values of the predetermined TopQ score by showing the variability above and below the TopQ score of 25 for 12x9 Wide, 28 for 6x6 Macula, and 30 for 6x6 Disc scans.
Outcome measures
| Measure |
12x9 Wide Scan
n=12 Participants
TopQ of 12x9 Wide Scan
|
6x6 Macula Scan
n=12 Participants
TopQ of 6x6 Macular Scan
|
6x6 Disc Scan
n=12 Participants
TopQ of 6x6 Disc Scan
|
|---|---|---|---|
|
TopQ Cut Off
Standard Deviation Below Threshold
|
17.54 microns
|
13.67 microns
|
13.67 microns
|
|
TopQ Cut Off
Standard Deviation Above Threshold
|
2.94 microns
|
1.5 microns
|
2.14 microns
|
Adverse Events
Subjects Presenting With Normal Eyes
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