Variability in Perimetry Study (VIP II)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01051739
First received: January 15, 2010
Last updated: March 26, 2014
Last verified: March 2014

January 15, 2010
March 26, 2014
July 2010
December 2014   (final data collection date for primary outcome measure)
time to significant visual field change [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01051739 on ClinicalTrials.gov Archive Site
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Variability in Perimetry Study
Improved Assessment of Visual Field Change

Improved Assessment of Visual Field Change is a trial aimed at investigating mechanisms of visual field testing variability. We have found using larger stimulus size substantially lowers short-term variability. In this study, we will determine if larger stimuli detect visual field change at an earlier time. We are also developing a statistical model that accounts for correlations of neighboring test locations.

Disease of the optic nerve, including glaucoma, is the leading cause of blindness in the United States. Treatment decisions for optic nerve diseases are based largely on the changes in visual function that occur mostly as a consequence of disease progression. Unfortunately, the decision as to whether change of visual function has occurred is often difficult because of the high retest variability of conventional visual field testing (perimetry). This variability is so high that with moderate visual loss, a minimum of six tests are often needed in patients with optic nerve damage to reliably distinguish visual field deterioration from random variation. Our preliminary data show that a substantial portion of the variability of perimetry lies in the type of stimulus used and the testing strategy applied.

OBJECTIVES: We propose to test the hypothesis that a large portion of total perimetric variability in patients with visual loss is due to a poor signal-to-noise ratio associated with using a small fixed-size stimulus.

RESEARCH PLAN AND METHODS: To test this hypothesis, we are examining patients with optic nerve diseases with conventional automated perimetry (size III) and tests having large-sized and scaled stimuli (size V, size VI (custom perimeter) and luminance size threshold perimetry - a test where threshold is found by changing stimulus size rather than stimulus intensity). Over four years we will test 100 patients with and glaucoma and 60 normals each eight times. In addition, we are retesting 50 subjects once a week for 5 weeks. We are also studying the associated structural-functional correlations using OCT and developing a statistical model that accounts for correlations of neighboring test locations.

Perimetric variability and the reliable identification of visual field change is the single most difficult problem in visual testing today. We anticipate identifying a method that allows efficient and accurate determination of visual field change. Identification of a superior method would (1) reduce the number of examinations needed, thereby reducing the costs of medical care; (2) minimize misdiagnosis, unnecessary testing and even unnecessary surgery that results from mistakenly interpreting fluctuation of the visual field as progression or improvement; (3) allow earlier disease intervention and (4) reduce the costs of clinical trials.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

glaucoma patient with 0 to -25 dB mean deviation and normal subjects

Visual Field
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  • Group 1
    glaucoma
  • Group 2
    normal
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
157
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Mean deviation of -20 or better with 5-8 points (optimally 10 points) with a value of p= 0.05 or better on the total deviation plot
  • Mild cataract with VA of 20/30 or better pinholed
  • Refractive error of = to or less than 6 diopters with = or less than 3.50 diopters of cylinder
  • Pupil diameter of 3 mm minimum
  • Controlled hypertension, diabetes, migraine
  • Pseudophakic/refractive surgery if no vision problems
  • Trabeculectomy okay if will progress

Exclusion Criteria:

  • History of other ocular or neurologic disease or surgery
  • History of stroke
  • Systemic disease [lupus, graves, cancer (within the last 5 yrs), AIDS, other]
  • History of amblyopia
  • Unreliable patient
  • Frequently misses appointments
  • Tests poorly
  • Ocular hypertension
  • Retinal problems
  • Diabetic retinopathy
  • Neurological disease (IIH, ON, AION)
  • Cancer not in remission for the last 5 years
  • Vein or artery occlusions
  • Macular degeneration
  • Trauma with vision loss
  • Ocular inflammation (pars planitis, iritis, temporal aeuritis)
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01051739
C7098-R
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Michael Wall, MD VA Medical Center, Iowa City
Department of Veterans Affairs
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP