N/A
N=104
Is the RAPDx Pupillograph Able to Distinguish Between Glaucoma Subjects and Healthy Subjects?
Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT02526693 ↗Enrolled (actual)
104
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Amplitude Asymmetry of Pupil Constriction — 0.8; 0.29; 0.5; 0.16 millimeters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pupillometer (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wills Eye
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Amplitude Asymmetry of Pupil Constriction |
0.8; 0.29; 0.5; 0.16 | — |
| PRIMARY Latency Asymmetry of Pupil Constriction |
0.22; 0.14; 0.2; 0.13 | — |
| PRIMARY Maximum Constriction Asymmetry Duration |
2.23; 1.92 | — |
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.
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 -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.
Data sourced from ClinicalTrials.gov (NCT02526693). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.