NCT01462526

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
798

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 31, 2011

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2016

Completed
Last Updated

October 12, 2017

Status Verified

October 1, 2017

Enrollment Period

5.1 years

First QC Date

October 27, 2011

Last Update Submit

October 10, 2017

Conditions

Study Arms (2)

Control

Participants who do not have glaucoma in either eye

Glaucoma

Participants who have glaucoma in one or both eyes

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with glaucoma, glaucoma suspects, or ocular hypertension who present to the glaucoma service at the Johns Hopkins Wilmer Eye Institute. We will also recruit normal subjects from the accompanying persons of patients attending examinations who are not blood relatives of the patient.

You may qualify if:

  • 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

You may not qualify if:

  • Ocular surgery in either eye within 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wilmer Eye Institute Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • David S Friedman, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2011

First Posted

October 31, 2011

Study Start

March 1, 2011

Primary Completion

March 31, 2016

Study Completion

March 31, 2016

Last Updated

October 12, 2017

Record last verified: 2017-10

Locations