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Completed

NCT Number: NCT01857440

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Havener Eye Institute, Columbus, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Acronym: FLIPR

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
May 20, 2013
Registry last updated
Sep 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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