NCT01076114

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

March 15, 2011

Status Verified

March 1, 2011

Enrollment Period

1 year

First QC Date

February 24, 2010

Last Update Submit

March 14, 2011

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Difference of mean deviation of glaucoma suspects from controls between critical flicker fusion and automated visual fields.

    1 visit (1 day)

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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)

You may not qualify if:

  • Other ocular pathology
  • History of seizures or epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nassau University Medical Center

East Meadow, New York, 11554, United States

Location

Related Publications (11)

  • 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.

    PMID: 10743346BACKGROUND

  • 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.

    PMID: 2387687BACKGROUND

  • 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.

    PMID: 18169373BACKGROUND

  • 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.

    PMID: 17891568BACKGROUND

  • 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.

    PMID: 18710429BACKGROUND

  • 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.

    PMID: 7305696BACKGROUND

  • Tyler CW. Specific deficits of flicker sensitivity in glaucoma and ocular hypertension. Invest Ophthalmol Vis Sci. 1981 Feb;20(2):204-12.

    PMID: 7461923BACKGROUND

  • 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.

    PMID: 9344350BACKGROUND

  • 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.

    PMID: 16637839BACKGROUND

  • 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.

    PMID: 2056646BACKGROUND

  • 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.

    PMID: 1922253BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Colin Scott, MD

    Nassau University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 24, 2010

First Posted

February 25, 2010

Study Start

February 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

March 15, 2011

Record last verified: 2011-03

Locations

US(1)