Trial Outcomes & Findings for Clinical Study of the Optic Disc Parameters (NCT NCT02277119)
NCT ID: NCT02277119
Last Updated: 2022-06-28
Results Overview
Reporting of the Optic Disc Size difference between the Maestro and iVue
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
109 participants
Primary outcome timeframe
1 Hour
Results posted on
2022-06-28
Participant Flow
Participant milestones
| Measure |
Normal Eyes
Subjects with no known ocular diseases will be scanned with the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes
|
Glaucomatous Eyes
Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes
|
Eyes With Retinal Diseases
Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes
|
|---|---|---|---|
|
Overall Study
STARTED
|
58
|
24
|
27
|
|
Overall Study
COMPLETED
|
55
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
8
|
Reasons for withdrawal
| Measure |
Normal Eyes
Subjects with no known ocular diseases will be scanned with the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes
|
Glaucomatous Eyes
Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes
|
Eyes With Retinal Diseases
Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
1
|
|
Overall Study
Protocol Violation
|
2
|
3
|
7
|
Baseline Characteristics
Clinical Study of the Optic Disc Parameters
Baseline characteristics by cohort
| Measure |
Normal Eyes
n=58 Participants
Subjects with no known ocular diseases will be scanned with the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes
|
Glaucomatous Eyes
n=24 Participants
Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes
|
Eyes With Retinal Diseases
n=27 Participants
Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes
|
Total
n=109 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
|
55 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Age, Continuous
|
39.2 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
57.8 years
STANDARD_DEVIATION 20.2 • n=7 Participants
|
60.5 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
48.7 years
STANDARD_DEVIATION 18.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=5 Participants
|
24 participants
n=7 Participants
|
27 participants
n=5 Participants
|
109 participants
n=4 Participants
|
|
Optic Disc Area Difference
|
0.197 Microns Squared
STANDARD_DEVIATION 0.228 • n=5 Participants
|
0.201 Microns Squared
STANDARD_DEVIATION 0.262 • n=7 Participants
|
0.097 Microns Squared
STANDARD_DEVIATION 0.216 • n=5 Participants
|
0.165 Microns Squared
STANDARD_DEVIATION 0.235 • n=4 Participants
|
PRIMARY outcome
Timeframe: 1 HourReporting of the Optic Disc Size difference between the Maestro and iVue
Outcome measures
| Measure |
Normal Eyes
n=58 Participants
Subjects with no known ocular diseases will be scanned with the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes
|
Glaucomatous Eyes
n=24 Participants
Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes
|
Eyes With Retinal Diseases
n=27 Participants
Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes
|
|---|---|---|---|
|
Optic Disc Measurements (Optic Disc Size)
|
0.197 Mircrons squared
Standard Deviation .228
|
0.097 Mircrons squared
Standard Deviation 0.216
|
0.201 Mircrons squared
Standard Deviation 0.262
|
PRIMARY outcome
Timeframe: 1 HourRNFL thickness measured
Outcome measures
| Measure |
Normal Eyes
n=58 Participants
Subjects with no known ocular diseases will be scanned with the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes
|
Glaucomatous Eyes
n=24 Participants
Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes
|
Eyes With Retinal Diseases
n=27 Participants
Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes
|
|---|---|---|---|
|
Retinal Nerve Fiber Layer (RNFL) Thickness Measurements
|
4.682 Microns
Standard Deviation 4.333
|
2.526 Microns
Standard Deviation 6.367
|
4.103 Microns
Standard Deviation 8.789
|
PRIMARY outcome
Timeframe: 1 HourPopulation: Glaucomatous eyes were not scanned and analyzed in the Full Retina Thickness portion of the study. Since the imaging is done in a different area of the eye compare to Retinal Nerve Fiber Layer participants analyzed will be different between these measurement areas.
Full Retinal Thicknesses Measurement
Outcome measures
| Measure |
Normal Eyes
n=19 Participants
Subjects with no known ocular diseases will be scanned with the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes
|
Glaucomatous Eyes
Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes
|
Eyes With Retinal Diseases
n=18 Participants
Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes
|
|---|---|---|---|
|
Full Retinal Thickness Measurement
|
22.845 Microns
Standard Deviation 11.482
|
—
|
21.299 Microns
Standard Deviation 24.524
|
PRIMARY outcome
Timeframe: 1 HourReporting of the Cup size difference between the Maestro and iVue
Outcome measures
| Measure |
Normal Eyes
n=58 Participants
Subjects with no known ocular diseases will be scanned with the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes
|
Glaucomatous Eyes
n=24 Participants
Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes
|
Eyes With Retinal Diseases
n=27 Participants
Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes
|
|---|---|---|---|
|
Optic Disc Measurement (Cup Size)
|
0 Microns cubed
Standard Deviation 0.072
|
-0.003 Microns cubed
Standard Deviation 0.124
|
0.016 Microns cubed
Standard Deviation 0.065
|
Adverse Events
Normal Eyes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Glaucomatous Eyes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Eyes With Retinal Diseases
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
Restriction type: GT60