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

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 42310
      • OSU College of Optometry
    • Columbus, Ohio, United States, 43212
      • Havener Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Survey	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.	Single Visit: One Day

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Andrew Hartwick, OD, PhD, OSU College of Optometry

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: May 13, 2013
• First Submitted That Met QC Criteria: May 15, 2013
• First Posted (Estimate): May 20, 2013

Study Record Updates

• Last Update Posted (Actual): September 25, 2017
• Last Update Submitted That Met QC Criteria: September 20, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Glaucoma; Pupil; Melanopsin
• Additional Relevant MeSH Terms: Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Eye Diseases
• Other Study ID Numbers: 2013H0073; 8KL2TR000112-05 (U.S. NIH Grant/Contract)