Glaucoma, Open-AngleFLIPRNCT01857440
The Flashing Light-Induced Pupil Response (FLIPR) Glaucoma Study
An observational study of Glaucoma, Open-Angle and Eye Diseases, run by Ohio State University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Open-Angle, Eye Diseases
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2013to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cases: Age 18 or older with diagnosed glaucoma of known severity Controls: Matched to Cases on age, sex, and race.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- History of retinopathy
- History of unreactive pupils
- Presence of significant cataract
Trial locations and contacts
2 sites in 1 country.
United States2 sites
OSU College of Optometry
Columbus, Ohio, 42310
Havener Eye Institute
Columbus, Ohio, 43212
About this 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.
Read the 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.
- Conditions
- Glaucoma, Open-Angle, Eye Diseases
- Keywords
- Glaucoma, Pupil, Melanopsin
- Medical subject headings
- Glaucoma, Open-Angle, Eye Diseases, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Single Visit: One Day
Secondary outcomes (1)
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.
Measured: Single Visit: One Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Hartwick, Ohio State University
- Investigators
- Andrew Hartwick, OD, PhD, Principal investigator, OSU College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857440
- Sponsor's protocol ID
- 2013H0073
- Other IDs
- 8KL2TR000112-05
- Acronym
- FLIPR
- Status last verified
- Sep 2017
- First submitted
- 13 May 2013
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Flashing Light-Induced Pupil Response (FLIPR) Glaucoma Study
- ClinicalTrials.gov ID
- NCT01857440
- Acronym / sponsor ID
- FLIPR / 2013H0073
- Conditions
- Glaucoma, Open-Angle, Eye Diseases
- Keywords
- Glaucoma, Pupil, Melanopsin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cases: Age 18 or older with diagnosed glaucoma of known severity Controls: Matched to Cases on age, sex, and race.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Quality of Life Survey
Time frame: Single Visit: One Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Results publicationShorter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Hartwick, OD, PhD principal investigator
OSU College of Optometry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, Open-Angle and Eye Diseases, run by Ohio State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pupil Response (time frame: Single Visit: One Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01857440, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.