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
  Purpose

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.


Condition
Visual Field

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Improved Assessment of Visual Field Change

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • time to significant visual field change [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 157
Study Start Date: July 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1
glaucoma
Group 2
normal

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01051739

Locations
United States, Iowa
VA Medical Center, Iowa City
Iowa City, Iowa, United States, 52246-2208
Sponsors and Collaborators
Investigators
Principal Investigator: Michael Wall, MD VA Medical Center, Iowa City
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01051739     History of Changes
Other Study ID Numbers: C7098-R
Study First Received: January 15, 2010
Last Updated: March 26, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
vision testing
perimetry
glaucoma
test variability

ClinicalTrials.gov processed this record on April 22, 2014