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

Glaucoma, Open-Angle Clinical Trial

— FLIPR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01857440
• Other study ID #: 2013H0073
• Secondary ID: 8KL2TR000112-05
• Status: Completed
• Phase: N/A
• First received: May 13, 2013
• Last updated: September 20, 2017
• Start date: May 2013
• Est. completion date: December 2015

Study information

• Verified date: September 2017
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eye Diseases
• Glaucoma
• Glaucoma, Open-Angle

Locations

Country	Name	City	State
United States	Havener Eye Institute	Columbus	Ohio
United States	OSU College of Optometry	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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