The Detection of Glaucoma Using Pupillography

NCT ID: NCT01462526

Last Updated: 2017-10-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 798 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2016-03-31

Brief Summary

Current screening methods for glaucoma detection are not perfect and nearly half of those in the United States with glaucoma go undiagnosed. Minority populations are even less likely to be diagnosed. Better screening methods are needed to identify the undiagnosed and to provide them care that can help them retain good vision.

Glaucoma is often more severe in one eye and this fact can be exploited in screening tests. The investigators plan to use a novel screening device that very accurately records the pupillary response from each eye. It is likely that patients with glaucoma will have abnormal responses when measured, and by comparing responses between the two eyes the investigators will be able to determine who has glaucoma. If this test works well, it will provide a low-cost way to screen populations at risk for glaucoma. Furthermore, this research will expand the knowledge base regarding how pupil responses to light differ between persons with and without glaucoma. Insights gained from this study will be useful in the development of an effective screening tool in the detection of glaucoma.

Detailed Description

Glaucoma is often asymmetric in nature, and an afferent pupillary defect (APD) is frequently present in persons with glaucoma. The investigators propose to conduct a clinic-based prospective study to assess the accuracy of using a binocular pupillographic device (RAPiD, Konan Medical, USA) to detect people with glaucoma. This device is designed to record and analyze pupil responses at multiple, controlled stimulus intensities, while using varied patterns and color stimuli.

The asymmetric nature of glaucoma suggests that a high proportion of persons with glaucoma will have an APD (although many may be subtle and would be missed with less refined testing methods). When glaucoma patients have severe nerve damage or when field loss is bilateral and symmetric, an APD may not be present or may be too small to detect. Noting this limitation, the investigators will compare pupillary responses to stimuli at different locations (for example the superior compared to the inferior hemifield) to determine whether the investigators can detect asymmetric glaucoma damage within the same eye. In addition, it is likely that the pupil response in glaucoma will be diminished when compared to normal, which will also help with detection.

Aim1: To examine the amplitude, latency and velocity of the pupil light reflex by optimizing its measurement to stimuli of various intensities and colors, and to characterize the variability of this response in normal subjects.

Aim2: To quantify the amount of structural loss (retinal nerve fiber layer thickness and optic nerve head parameters) and functional loss (visual field mean deviation) necessary for an APD (as detected by RAPiD) to manifest.

Aim3a: To develop an algorithm that best discriminates those with and without glaucoma by individual or combined use of 1) detecting an APD between the two eyes, 2) comparing pupil responses in different parts of the visual field within the same eye, and 3) comparing responses of diseased eyes to responses of "normal" eyes.

Aim 3b: To assess the validity of this algorithm in glaucoma detection and to assess the reproducibility of the pupil response measurements at a follow-up visit within 7 months.

Conditions

Glaucoma

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Control

Participants who do not have glaucoma in either eye

No interventions assigned to this group

Glaucoma

Participants who have glaucoma in one or both eyes

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age 40 years or older at enrollment
• Presenting visual acuity better than 20/100 in both eyes
• Spherical equivalent refractive error within the range of 4.0 and -6.0 diopters in both eyes

Exclusion Criteria

• Ocular surgery in either eye within 3 months

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David S Friedman, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Wilmer Eye Institute Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00044899

Identifier Type: -

Identifier Source: org_study_id