Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01857440
Recruitment Status : Completed
First Posted : May 20, 2013
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Andrew Hartwick, Ohio State University

Tracking Information
First Submitted Date May 13, 2013
First Posted Date May 20, 2013
Last Update Posted Date September 25, 2017
Study Start Date May 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 15, 2013)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 15, 2013)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Flashing Light-Induced Pupil Response (FLIPR) Glaucoma Study
Official Title The Flashing Light-Induced Pupil Response (FLIPR) Glaucoma Study
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Glaucoma, Open-Angle
  • Eye Diseases
Intervention Not Provided
Study Groups/Cohorts
  • 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.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 20, 2017)
32
Original Estimated Enrollment
 (submitted: May 15, 2013)
80
Actual Study Completion Date December 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01857440
Other Study ID Numbers 2013H0073
8KL2TR000112-05 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Andrew Hartwick, Ohio State University
Study Sponsor Ohio State University
Collaborators Not Provided
Investigators
Principal Investigator: Andrew Hartwick, OD, PhD OSU College of Optometry
PRS Account Ohio State University
Verification Date September 2017