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

Completed

• Conditions: Glaucoma, Open-Angle; Eye Diseases

• Registration Number: NCT01857440
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-13
• Study First Submitted QC: 2013-05-15
• Study First Posted: 2013-05-20
• Primary Completion: 2014-12
• Study Completion: 2015-12
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-20
• Last Update Posted: 2017-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pupil Response	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

Name	Time	Method
Quality of Life Survey	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.

Trial Locations

Locations (2)

OSU College of Optometry; 🇺🇸 Columbus, Ohio, United States

Havener Eye Institute; 🇺🇸 Columbus, Ohio, United States