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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01857440
Recruitment Status : Completed
First Posted : May 20, 2013
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Andrew Hartwick, Ohio State University

Brief Summary:
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.

Condition or disease
Glaucoma, Open-Angle Eye Diseases

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Flashing Light-Induced Pupil Response (FLIPR) Glaucoma Study
Study Start Date : May 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Group/Cohort
Subjects with glaucoma (Cases)
This group will consist of patients with glaucoma who are under care at the Ohio State University Havener Eye Institute.
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.



Primary Outcome Measures :
  1. Pupil Response [ Time Frame: Single Visit: One Day ]
    Using fourier analysis, the pupil fluctuation evoked by blue and red flickering lights will be measured in glaucoma patients and compared to matched controls.


Secondary Outcome Measures :
  1. Quality of Life Survey [ Time Frame: Single Visit: One Day ]
    Subjects will fill out a questionnaire with questions that assess quality of life issues, and the results will be correlated to the pupil response data.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Cases: Age 18 or older with diagnosed glaucoma of known severity Controls: Matched to Cases on age, sex, and race.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857440


Locations
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United States, Ohio
OSU College of Optometry
Columbus, Ohio, United States, 42310
Havener Eye Institute
Columbus, Ohio, United States, 43212
Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: Andrew Hartwick, OD, PhD OSU College of Optometry
Publications of Results:
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.

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Responsible Party: Andrew Hartwick, Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01857440    
Other Study ID Numbers: 2013H0073
8KL2TR000112-05 ( U.S. NIH Grant/Contract )
First Posted: May 20, 2013    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Keywords provided by Andrew Hartwick, Ohio State University:
Glaucoma
Pupil
Melanopsin
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Eye Diseases
Ocular Hypertension