An interventional study of Pupillometer in Glaucoma, sponsored by Wills Eye. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-23.
Sponsored by Wills Eye · Not applicable, Interventional, and Diagnostic
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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This study's enrollment of 104 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.
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Glaucoma patients:
Healthy subjects:
Exclusion Criteria:
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.
Diagnostic Test: Pupillometer
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.
Diagnostic Test: Pupillometer
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.
Also known as: Relative afferent pupillary defect pupillometer
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.
Time frame: 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.
Time frame: 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.
Time frame: 1 examination, one hour
| Milestone | Glaucoma Patients | Healthy Controls |
|---|---|---|
| Started | 53 | 51 |
| Completed | 50 | 50 |
| Not completed | 3 | 1 |
| Withdrew: Physician decision | 3 | 1 |
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.
| millimeters | Glaucoma Patients | Healthy Controls |
|---|---|---|
| Custom sequence | 0.8 ± 0.75 | 0.29 ± 0.27 |
| Standard sequence | 0.5 ± 0.52 | 0.16 ± 0.12 |
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.
| milliseconds | Glaucoma | Healthy Controls |
|---|---|---|
| Custom sequence | 0.22 ± 0.23 | 0.14 ± 0.14 |
| Standard sequence | 0.2 ± 0.21 | 0.13 ± 0.11 |
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.
| milliseconds | Glaucoma Patients | Healthy Controls |
|---|---|---|
| Maximum Constriction Asymmetry Duration | 2.23 ± 0.64 | 1.92 ± 0.54 |
Collected over 1 examination, one hour. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Glaucoma Patients | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Healthy Controls | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
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.
| Age, Categorical(Participants) | Glaucoma | Healthy Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 23 | 34 | 57 |
| >=65 years | 27 | 16 | 43 |
| Sex: Female, Male(Participants) | Glaucoma | Healthy Control | Total |
|---|---|---|---|
| Female | 31 | 33 | 64 |
| Male | 19 | 17 | 36 |
| Race (NIH/OMB)(Participants) | Glaucoma | Healthy Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 3 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 37 | 14 | 51 |
| White | 9 | 29 | 38 |
| More than one race | 2 | 4 | 6 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Glaucoma | Healthy Control | Total |
|---|---|---|---|
| United States | 50 | 50 | 100 |
No study locations are listed for this record.
Plan to share: No — Manuscript is has not been finalized.
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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