Back to resultsIs the RAPDx Pupillograph Able to Distinguish Between Glaucoma Subjects and Healthy Subjects?
Primary Purpose
Glaucoma
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pupillometer
Sponsored by
About this trial
This is an interventional diagnostic trial for Glaucoma focused on measuring glaucoma, relative afferent pupillary defect, pupillography
Eligibility Criteria
Inclusion Criteria:
Glaucoma patients:
- optic nerve damage (neuroretinal rim notch, asymmetric inter-eye cup to disc (c/d_ ratio >0.2 or disc damage likelihood scale (DDLS) >2, or absence of neuroretinal rim not due to other cause)
- glaucomatous visual field (VF) deficits (cluster of 3 or more points on pattern deviation plot depressed below 5% level, at least 1 depressed below 1% level; OR corrected pattern standard deviation/pattern standard deviation significant at P <0.05; or glaucoma hemifield test "outside normal limits") with good reliability indices (fixation losses, false-positive rate, false-negative rate each < 33%).
Healthy subjects:
- normal optic nerve exam
- normal reliable VF (Humphrey mean deviation (MD) >-2 or Octopus MD ≤0.8; fixation losses, false-positive rate, and false-negative rate each < 33%)
- open angles gonioscopy.
Exclusion Criteria:
- Abnormal ocular motility preventing binocular fixation (e.g. strabismus, nystagmus).
- Any condition preventing adequate visualization and examination of pupil or optic nerve (e.g. dense corneal opacities or lens opacities).
- Active infection of anterior or posterior segments of the eye.
- Any intraocular surgical or laser procedure within previous 4 weeks.
- Any non-glaucomatous condition causing RAPD, anisocoria or corectopia (ex. optic neuropathy, Horner's syndrome, previous iris injury due to trauma or surgery, etc.).
- Subjects under age 18 or subjects presently housed in correctional facility.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Glaucoma Patients
Healthy Controls
Arm Description
Glaucoma patients recruited from Wills Eye Hospital Glaucoma Service will be tested with the relative afferent pupillary defect test (RAPDx) Pupillometer. The noninvasive RAPDx measures the pupils response during light stimulation.
Healthy subjects with no eye diseases recruited from Wills Eye Hospital Glaucoma Service staff, family and friends will be tested with the relative afferent pupillary defect test (RAPDx) Pupillometer. The noninvasive RAPDx measures the pupils response during light stimulation.
Outcomes
Primary Outcome Measures
Amplitude Asymmetry of Pupil Constriction
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.
Latency Asymmetry of Pupil Constriction
Pupil 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.
Maximum Constriction Asymmetry Duration
Log 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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02526693
Brief Title
Is the RAPDx Pupillograph Able to Distinguish Between Glaucoma Subjects and Healthy Subjects?
Official Title
RAPDx Pupillography for Early Detection of Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wills Eye
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The Konan RAPDx (Konan Medical USA, Irvine, CA) is a newly patented pupillography device.The aims of this study are to assess the ability of the RAPDx to distinguish between healthy subjects and patients with confirmed glaucoma using standard testing sequences developed for use at the Wills Eye Hospital Glaucoma Research Center and to determine the combination of demographic, clinical, and RAPDx testing parameters which allow for maximum sensitivity and specificity.
Detailed Description
The RAPDx utilizes noninvasive digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify the pupillary response to light.
During the scheduled appointment, all patients will receive an undilated fundus examination by the attending ophthalmologist. The following data will be collected; Demographic information, Visual acuity, Intraocular pressure (IOP) measured by Goldmann applanation tonometry, Disc damage likelihood scale (DDLS), Vertical cup/disc ratio, Gonioscopy (if not documented in the chart within the past 2 years) and Humphrey visual field examination.
Each participant will undergo RAPDx testing with two different testing sequences. They are separated by a 10-second resting period during which the patient is instructed to close his or her eyes. The exam may be paused at any time and re-alignment may be performed during any pause. The two testing sequences are:
Standard Factory Setting: 0.1-second stimuli with 2-second inter-stimuli pauses;
Custom Setting: 3-second stimuli with 1-second inter-stimuli pauses
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
glaucoma, relative afferent pupillary defect, pupillography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glaucoma Patients
Arm Type
Other
Arm Description
Glaucoma patients recruited from Wills Eye Hospital Glaucoma Service will be tested with the relative afferent pupillary defect test (RAPDx) Pupillometer. The noninvasive RAPDx measures the pupils response during light stimulation.
Arm Title
Healthy Controls
Arm Type
Other
Arm Description
Healthy subjects with no eye diseases recruited from Wills Eye Hospital Glaucoma Service staff, family and friends will be tested with the relative afferent pupillary defect test (RAPDx) Pupillometer. The noninvasive RAPDx measures the pupils response during light stimulation.
Intervention Type
Diagnostic Test
Intervention Name(s)
Pupillometer
Other Intervention Name(s)
Relative afferent pupillary defect pupillometer
Intervention Description
The Konan RAPDx (relative afferent pupillary defect) (Konan Medical USA, Irvine, CA) pupillometer utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify pupillary response to light.
Primary Outcome Measure Information:
Title
Amplitude Asymmetry of Pupil Constriction
Description
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.
Time Frame
1 examination, one hour
Title
Latency Asymmetry of Pupil Constriction
Description
Pupil 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.
Time Frame
1 examination, one hour
Title
Maximum Constriction Asymmetry Duration
Description
Log 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.
Time Frame
1 examination, one hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Glaucoma patients:
optic nerve damage (neuroretinal rim notch, asymmetric inter-eye cup to disc (c/d_ ratio >0.2 or disc damage likelihood scale (DDLS) >2, or absence of neuroretinal rim not due to other cause)
glaucomatous visual field (VF) deficits (cluster of 3 or more points on pattern deviation plot depressed below 5% level, at least 1 depressed below 1% level; OR corrected pattern standard deviation/pattern standard deviation significant at P <0.05; or glaucoma hemifield test "outside normal limits") with good reliability indices (fixation losses, false-positive rate, false-negative rate each < 33%).
Healthy subjects:
normal optic nerve exam
normal reliable VF (Humphrey mean deviation (MD) >-2 or Octopus MD ≤0.8; fixation losses, false-positive rate, and false-negative rate each < 33%)
open angles gonioscopy.
Exclusion Criteria:
Abnormal ocular motility preventing binocular fixation (e.g. strabismus, nystagmus).
Any condition preventing adequate visualization and examination of pupil or optic nerve (e.g. dense corneal opacities or lens opacities).
Active infection of anterior or posterior segments of the eye.
Any intraocular surgical or laser procedure within previous 4 weeks.
Any non-glaucomatous condition causing RAPD, anisocoria or corectopia (ex. optic neuropathy, Horner's syndrome, previous iris injury due to trauma or surgery, etc.).
Subjects under age 18 or subjects presently housed in correctional facility.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Spaeth, MD
Organizational Affiliation
Wills Eye Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Manuscript is has not been finalized.
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Is the RAPDx Pupillograph Able to Distinguish Between Glaucoma Subjects and Healthy Subjects?
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