Trial Outcomes & Findings for Is the RAPDx Pupillograph Able to Distinguish Between Glaucoma Subjects and Healthy Subjects? (NCT NCT02526693)
NCT ID: NCT02526693
Last Updated: 2019-10-23
Results Overview
Pupil size changes when light shines into the eyes making the diameter of the pupil smaller (constriction). The size of the pupil's reaction to light, measured in millimeters, is the amplitude or change in diameter. Amplitude of maximum pupil constriction (pupil size) when light is shone is compared between the right and left eyes. Asymmetry is the difference between maximum pupil size of the two eyes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
104 participants
Primary outcome timeframe
1 examination, one hour
Results posted on
2019-10-23
Participant Flow
Participant milestones
| Measure |
Glaucoma Patients
50 Glaucoma patients recruited from Wills Eye Hospital Glaucoma Service will be tested with RAPDx Pupillometer machine.
RAPDx Pupillometer: Konan relative afferent pupillary defect RAPDx (Konan Medical USA, Irvine, CA) utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify pupillary response to light.
|
Healthy Controls
50 Healthy subjects with no eye diseases from Wills Eye Hospital Glaucoma Service staff, family and friends will be tested with RAPDx Pupillometer machine.
RAPDx Pupillometer: Konan relative afferent pupillary defect RAPDx (Konan Medical USA, Irvine, CA) utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify pupillary response to light.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
51
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Glaucoma Patients
50 Glaucoma patients recruited from Wills Eye Hospital Glaucoma Service will be tested with RAPDx Pupillometer machine.
RAPDx Pupillometer: Konan relative afferent pupillary defect RAPDx (Konan Medical USA, Irvine, CA) utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify pupillary response to light.
|
Healthy Controls
50 Healthy subjects with no eye diseases from Wills Eye Hospital Glaucoma Service staff, family and friends will be tested with RAPDx Pupillometer machine.
RAPDx Pupillometer: Konan relative afferent pupillary defect RAPDx (Konan Medical USA, Irvine, CA) utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify pupillary response to light.
|
|---|---|---|
|
Overall Study
Physician Decision
|
3
|
1
|
Baseline Characteristics
Is the RAPDx Pupillograph Able to Distinguish Between Glaucoma Subjects and Healthy Subjects?
Baseline characteristics by cohort
| Measure |
Glaucoma
n=50 Participants
Glaucoma patients are recruited from Wills Eye Hospital glaucoma service, who will be tested with the RAPDx Pupillography machine.
RAPDx Pupillography: The Konan RAPDx (Konan Medical USA, Irvine, CA) utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify the pupillary response to light.
|
Healthy Control
n=50 Participants
Healthy subjects are recruited from Wills Eye Hospital primary care service, who will be tested with the RAPDx Pupillography machine.
RAPDx Pupillography: The Konan RAPDx (Konan Medical USA, Irvine, CA) utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify the pupillary response to light.
|
Total
n=100 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
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
27 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
37 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
100 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 examination, one hourPupil size changes when light shines into the eyes making the diameter of the pupil smaller (constriction). The size of the pupil's reaction to light, measured in millimeters, is the amplitude or change in diameter. Amplitude of maximum pupil constriction (pupil size) when light is shone is compared between the right and left eyes. Asymmetry is the difference between maximum pupil size of the two eyes.
Outcome measures
| Measure |
Glaucoma Patients
n=50 Participants
Glaucoma patients recruited from Glaucoma Service at Wills Eye Hospital will be tested with RAPDx Pupillography machine
Relative afferent pupillary defect RAPDx Pupillography: The Konan RAPDx (Konan Medical USA, Irvine, CA) utilizes digital, high-definition, infrared with eye-tracking and automated blink detection to analyze and quantify pupillary response to light and dark with a standard testing sequence and a custom sequence.
|
Healthy Controls
n=50 Participants
Healthy subjects are recruited from the Wills Eye clinic, who will be tested with the RAPDx Pupillography machine
Relative afferent pupillary defect RAPDx Pupillography: The Konan RAPDx (Konan Medical USA, Irvine, CA) utilizes digital, high-definition, infrared with eye-tracking and automated blink detection to analyze and quantify pupillary response to light and dark with a standard testing sequence and a custom sequence.
|
|---|---|---|
|
Amplitude Asymmetry of Pupil Constriction
Custom sequence
|
0.8 millimeters
Standard Deviation 0.75
|
0.29 millimeters
Standard Deviation 0.27
|
|
Amplitude Asymmetry of Pupil Constriction
Standard sequence
|
0.5 millimeters
Standard Deviation 0.52
|
0.16 millimeters
Standard Deviation 0.12
|
PRIMARY outcome
Timeframe: 1 examination, one hourPupil size changes at different speeds when light shines into the eyes making the diameter of the pupil smaller (constriction). The speed of the pupil's reaction to light is the latency or amount of time. Latency of maximum pupil constriction when light is shone is compared between the right and left eyes. Asymmetry is the difference in time it takes for maximum pupil constriction between the two eyes.
Outcome measures
| Measure |
Glaucoma Patients
n=50 Participants
Glaucoma patients recruited from Glaucoma Service at Wills Eye Hospital will be tested with RAPDx Pupillography machine
Relative afferent pupillary defect RAPDx Pupillography: The Konan RAPDx (Konan Medical USA, Irvine, CA) utilizes digital, high-definition, infrared with eye-tracking and automated blink detection to analyze and quantify pupillary response to light and dark with a standard testing sequence and a custom sequence.
|
Healthy Controls
n=50 Participants
Healthy subjects are recruited from the Wills Eye clinic, who will be tested with the RAPDx Pupillography machine
Relative afferent pupillary defect RAPDx Pupillography: The Konan RAPDx (Konan Medical USA, Irvine, CA) utilizes digital, high-definition, infrared with eye-tracking and automated blink detection to analyze and quantify pupillary response to light and dark with a standard testing sequence and a custom sequence.
|
|---|---|---|
|
Latency Asymmetry of Pupil Constriction
Custom sequence
|
0.22 milliseconds
Standard Deviation 0.23
|
0.14 milliseconds
Standard Deviation 0.14
|
|
Latency Asymmetry of Pupil Constriction
Standard sequence
|
0.2 milliseconds
Standard Deviation 0.21
|
0.13 milliseconds
Standard Deviation 0.11
|
PRIMARY outcome
Timeframe: 1 examination, one hourLog difference between duration of maximum pupil constriction when light is shone into the right versus the left eye. The duration of maximum constriction is calculated as time in milliseconds between point of maximum constriction and time when pupil amplitude has reached 50% of peak amplitude of dilation.
Outcome measures
| Measure |
Glaucoma Patients
n=50 Participants
Glaucoma patients recruited from Glaucoma Service at Wills Eye Hospital will be tested with RAPDx Pupillography machine
Relative afferent pupillary defect RAPDx Pupillography: The Konan RAPDx (Konan Medical USA, Irvine, CA) utilizes digital, high-definition, infrared with eye-tracking and automated blink detection to analyze and quantify pupillary response to light and dark with a standard testing sequence and a custom sequence.
|
Healthy Controls
n=50 Participants
Healthy subjects are recruited from the Wills Eye clinic, who will be tested with the RAPDx Pupillography machine
Relative afferent pupillary defect RAPDx Pupillography: The Konan RAPDx (Konan Medical USA, Irvine, CA) utilizes digital, high-definition, infrared with eye-tracking and automated blink detection to analyze and quantify pupillary response to light and dark with a standard testing sequence and a custom sequence.
|
|---|---|---|
|
Maximum Constriction Asymmetry Duration
|
2.23 milliseconds
Standard Deviation 0.64
|
1.92 milliseconds
Standard Deviation 0.54
|
Adverse Events
Glaucoma Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Controls
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