Is the RAPDx Pupillograph Able to Distinguish Between Glaucoma Subjects and Healthy Subjects?

NCT02526693 | Completed Results

• 1 other identifier: 14-400E
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glaucoma

Keywords

glaucoma; relative afferent pupillary defect; pupillography

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

Diagnostic Test: Pupillometer

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.

Diagnostic Test: Pupillometer

Interventions

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.

Also known as: Relative afferent pupillary defect pupillometer

Glaucoma Patients; Healthy Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wills Eye: lead

MeSH Terms

Conditions

Glaucoma; Pupil Disorders

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Small sample size. Single site design. Single light design limits pupil stimulus.

Results Point of Contact

• Title: George L. Spaeth, MD
• Organization: Wills Eye Hospital

gspaeth@willseye.org

215-928-3123

Study Officials

• George Spaeth, MD

  Wills Eye Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 6, 2015
• First Posted: August 18, 2015
• Study Start: June 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 23, 2019
• Results First Posted: October 23, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share