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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glaucoma Patients | Other | 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. |
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| Healthy Controls | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pupillometer | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 examination, one hour |
| 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. | 1 examination, one hour |
| 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. | 1 examination, one hour |
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Inclusion Criteria:
Glaucoma patients:
Healthy subjects:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Spaeth, MD | Wills Eye Hospital | Principal Investigator |
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Manuscript is has not been finalized.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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4 participants enrolled were excluded from analysis due to other comorbidities or abnormal values of measurement parameters. Three excluded participants were from the Glaucoma Group, one was from the Control Group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Glaucoma | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | millimeters | 1 examination, one hour |
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1 examination, one hour
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Glaucoma Patients | 50 Glaucoma patients recruited from Wills Eye Hospital Glaucoma Service were tested with RAPDx Pupillometer. Konan (Konan Medical USA, Irvine, CA) RAPDx (relative afferent pupillary defect) test utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify pupillary response to light. |
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Small sample size. Single site design. Single light design limits pupil stimulus.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| George L. Spaeth, MD | Wills Eye Hospital | 215-928-3123 | gspaeth@willseye.org |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D011681 | Pupil Disorders |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| BG001 | Healthy Control | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Glaucoma patients were recruited from Wills Eye Hospital Glaucoma Service, Philadelphia, PA, USA. Healthy controls were recruited from staff, friends and family members of Wills Eye Hospital Glaucoma Research Center. | Number | participants |
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| OG001 | Healthy Controls | 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. |
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| Primary | 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. | Posted | Mean | Standard Deviation | milliseconds | 1 examination, one hour |
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| Primary | 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. | Posted | Mean | Standard Deviation | milliseconds | 1 examination, one hour |
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| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Healthy Controls | 50 Healthy controls recruited from Wills Eye Hospital Glaucoma Service staff, family and friends were tested with RAPDx Pupillometer. Konan (Konan Medical USA, Irvine, CA) RAPDx (relative afferent pupillary defect) test utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify pupillary response to light. | 0 | 50 | 0 | 50 | 0 | 50 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |