Clinical trial NCT02526693: 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
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: glaucoma
relative afferent pupillary defect
pupillography
Lead sponsor: Wills Eye
Sponsor class: OTHER
First posted: 2015-08-18
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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:

1. Standard Factory Setting: 0.1-second stimuli with 2-second inter-stimuli pauses;
2. Custom Setting: 3-second stimuli with 1-second inter-stimuli pauses

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.

Primary outcomes:
measure: Amplitude Asymmetry of Pupil Constriction
timeFrame: 1 examination, one hour
measure: Latency Asymmetry of Pupil Constriction
timeFrame: 1 examination, one hour
measure: Maximum Constriction Asymmetry Duration
timeFrame: 1 examination, one hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wills Eye Hospital
name: George Spaeth, MD
role: PRINCIPAL_INVESTIGATOR
References: