NCT02526693

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

RAPDx Pupillography for Early Detection of Glaucoma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Wills Eye · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Glaucoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2015-08-18
• Last updated: 2019-10-23
• Results posted: 2019-10-23