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The Flashing Light-Induced Pupil Response (FLIPR) Glaucoma Study

NCT ID: NCT01857440

Last Updated: 2017-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-12-31

Brief Summary

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This study is designed to investigate whether the pupil response to slowly flashing colored lights is significantly altered in patients with glaucoma, as compared to a control group of subjects without glaucoma.

Detailed Description

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The pupils inside the eyes constrict in response to light stimulation. Different classes of cells within the human retina initiate this response. Recent research suggests that one of the ganglion cell types involved in this pupil response is affected by glaucoma. By measuring pupil responses to different colored lights, the function of this class of cells can be evaluated quickly, and without touching the eye. An advantage of pupil testing strategies is that they do not require subjective feedback from the subject about what they can see, as is required for standard visual field tests that are used in the clinic.

The main aim of this study is to measure and compare the pupil constriction that occurs in response to flickering red and blue lights in patients with glaucoma versus matched control patients without glaucoma. In addition, the subjects will be asked questions about their quality of life and it will be determined whether issues related to quality of life correlate to alterations in the pupil responses.

Conditions

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Glaucoma, Open-Angle Eye Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Subjects with glaucoma (Cases)

This group will consist of patients with glaucoma who are under care at the Ohio State University Havener Eye Institute.

No interventions assigned to this group

Subjects without glaucoma (Controls)

This group will consist of matched controls who are free of glaucoma and other complications, and who received a comprehensive eye examination at the Ohio State University College of Optometry.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 18+ years old
* Diagnosed with glaucoma of known severity (cases only)
* Have a refractive error between +4.00 and -8.00 sphere power, and no more than 3.00 diopters of astigmatism
* Best corrected visual acuity of 20/40 or better in each eye
* Have open anterior chamber angles

Exclusion Criteria

* Diagnosis of glaucoma of a type other than Primary Open Angle (cases only)
* History of having surgery or taking medications known to profoundly affect pupillary function or shape
* Visual Field defect (controls only)
* History of traumatic brain injury requiring hospitalization
* Pregnancy
* History of optic nerve disease other than glaucoma
* History of retinopathy
* History of unreactive pupils
* Presence of significant cataract
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Andrew Hartwick

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew Hartwick, OD, PhD

Role: PRINCIPAL_INVESTIGATOR

OSU College of Optometry

Locations

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OSU College of Optometry

Columbus, Ohio, United States

Site Status

Havener Eye Institute

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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Shorter P, Eren D, Jain SG, Hartwick ATE. 2014. The flashing light-induced pupil response (FLIPR) glaucoma study. Invest. Ophthalmol. & Vis. Sci. 55: E-abstract 5608.

Reference Type RESULT

Other Identifiers

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8KL2TR000112-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2013H0073

Identifier Type: -

Identifier Source: org_study_id