Clinical trial NCT01857440: The Flashing Light-Induced Pupil Response (FLIPR) Glaucoma Study
Official title: The Flashing Light-Induced Pupil Response (FLIPR) Glaucoma Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma, Open-Angle
Eye Diseases
Keywords: Glaucoma
Pupil
Melanopsin
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2013-05-20
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility 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

Primary outcomes:
measure: Pupil Response
timeFrame: Single Visit: One Day
Secondary outcomes:
measure: Quality of Life Survey
timeFrame: Single Visit: One Day
Other outcomes:
Locations:
city: Columbus
country: United States
facility: OSU College of Optometry
state: Ohio
city: Columbus
country: United States
facility: Havener Eye Institute
state: Ohio
Study officials:
affiliation: OSU College of Optometry
name: Andrew Hartwick, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.