- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01076114
Comparison of Critical Flicker Fusion Versus Automated Visual Fields in the Detection of Early Glaucoma
March 14, 2011 updated by: Northwell Health
Comparison of Critical Flicker Fusion vs. Automated Visual Fields in the Detection of Early Glaucoma
The purpose of this study is to evaluate if critical flicker fusion is a more reliable method for detection of early glaucoma compared to automated visual fields in comparison to subjects without evidence of glaucoma or optic nerve disease.
Study Overview
Status
Completed
Conditions
Detailed Description
Our hypothesis is that critical flicker fusion (CFF) is a more reliable method for detection of early glaucoma compared to automated visual fields in comparison to subjects without evidence of glaucoma or optic nerve disease.
We aim to evaluate the structure of the optic nerve and compare it to results of visual fields and CFF.
The CFF will also be correlated with intraocular pressure (IOP) measurements to observe if it may be more closely related than visual fields.
This may become an additional tool to detect glaucoma in those with unreliable visual fields or who are unable to perform a visual field from physical or mental limitations.
Study Type
Observational
Enrollment (Actual)
58
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
East Meadow, New York, United States, 11554
- Nassau University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Subjects will be selected from routine clinic patients seen at the Eye Center at Nassau University Medical Center, in East Meadow, NY.
Description
Inclusion:
- Glaucoma Suspects:
- Abnormal optic disc appearance with increased cup to disc ratio, or
- Increased intraocular pressure >21 in either eye
- Control Subjects:
- Normal appearing optic discs
- Normal intraocular pressure (<21)
Exclusion:
- Other ocular pathology
- History of seizures or epilepsy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Control
Patients with no evidence of glaucoma or as a suspect with normal intraocular pressure, normal cup to disc ratio with no other ocular pathology and a normal ophthalmic exam.
|
|
Glaucoma Suspect
Patients with abnormal cup to disc ratio or increased intraocular pressure (>21mm/Hg) with an otherwise normal ophthalmic exam.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Difference of mean deviation of glaucoma suspects from controls between critical flicker fusion and automated visual fields.
Time Frame: 1 visit (1 day)
|
1 visit (1 day)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Colin Scott, MD, Nassau University Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Chen PC, Woung LC, Yang CF. Modulation transfer function and critical flicker frequency in high-myopia patients. J Formos Med Assoc. 2000 Jan;99(1):45-8.
- Van Toi V, Grounauer PA, Burckhardt CW. Artificially increasing intraocular pressure causes flicker sensitivity losses. Invest Ophthalmol Vis Sci. 1990 Aug;31(8):1567-74.
- Riddell LA. THE USE OF THE FLICKER PHENOMENON IN THE INVESTIGATION OF THE FIELD OF VISION. Br J Ophthalmol. 1936 Jul;20(7):385-410. doi: 10.1136/bjo.20.7.385. No abstract available.
- Chang TT, Ciuffreda KJ, Kapoor N. Critical flicker frequency and related symptoms in mild traumatic brain injury. Brain Inj. 2007 Sep;21(10):1055-62. doi: 10.1080/02699050701591437.
- Sharma P, Sharma BC, Tyagi P, Kumar M, Sarin SK. Neuropsychological impairment in severe acute viral hepatitis is due to minimal hepatic encephalopathy. Liver Int. 2009 Feb;29(2):260-4. doi: 10.1111/j.1478-3231.2008.01856.x. Epub 2008 Aug 14.
- Patterson VH, Foster DH, Heron J, Mason RJ. Multiple sclerosis. Luminance threshold and measurements of temporal characteristics of vision. Arch Neurol. 1981 Nov;38(11):687-9. doi: 10.1001/archneur.1981.00510110047005.
- Tyler CW. Specific deficits of flicker sensitivity in glaucoma and ocular hypertension. Invest Ophthalmol Vis Sci. 1981 Feb;20(2):204-12.
- Yoshiyama KK, Johnson CA. Which method of flicker perimetry is most effective for detection of glaucomatous visual field loss? Invest Ophthalmol Vis Sci. 1997 Oct;38(11):2270-7.
- Matsumoto C, Takada S, Okuyama S, Arimura E, Hashimoto S, Shimomura Y. Automated flicker perimetry in glaucoma using Octopus 311: a comparative study with the Humphrey Matrix. Acta Ophthalmol Scand. 2006 Apr;84(2):210-5. doi: 10.1111/j.1600-0420.2005.00588.x.
- Tielsch JM, Sommer A, Katz J, Royall RM, Quigley HA, Javitt J. Racial variations in the prevalence of primary open-angle glaucoma. The Baltimore Eye Survey. JAMA. 1991 Jul 17;266(3):369-74.
- Javitt JC, McBean AM, Nicholson GA, Babish JD, Warren JL, Krakauer H. Undertreatment of glaucoma among black Americans. N Engl J Med. 1991 Nov 14;325(20):1418-22. doi: 10.1056/NEJM199111143252005.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
February 1, 2011
Study Completion (Actual)
February 1, 2011
Study Registration Dates
First Submitted
February 24, 2010
First Submitted That Met QC Criteria
February 24, 2010
First Posted (Estimate)
February 25, 2010
Study Record Updates
Last Update Posted (Estimate)
March 15, 2011
Last Update Submitted That Met QC Criteria
March 14, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-320
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.