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Variability in Perimetry Study (VIPII)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01051739
First received: January 15, 2010
Last updated: February 13, 2017
Last verified: February 2017
  Purpose
Improved Assessment of Visual Field Change is a trial aimed at investigating mechanisms of visual field testing variability. The investigators have found using larger stimulus size substantially lowers short-term variability. In this study, the investigators will determine if larger stimuli detect visual field change at an earlier time. The investigators are also developing a statistical model that accounts for correlations of neighboring test locations.

Condition Intervention
Glaucoma Procedure: Comparison of four visual field testing strategies

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 VA Office of Research and Development:

Primary Outcome Measures:
  • Number of Subjects Progressing in Each Group Using Pointwise Linear Regression [ Time Frame: 4 years ]
    Perimetric method that most efficiently detects visual field change. secondary outcome: number of subjects progressing in each group using pointwise linear regression Linear regression was used to determine visual field worsening (progression) at each of 52 test locations. We required 3 or more worsening test locations at a p = 0.05 significance level for their to be significant progression.


Enrollment: 180
Study Start Date: July 2010
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
glaucoma
Procedure: Comparison of four visual field testing strategies
We compared the ability of four perimetric strategies to detect visual field change in the glaucoma arm.
Group 2
normal
Procedure: Comparison of four visual field testing strategies
We compared the ability of four perimetric strategies to detect visual field change in the glaucoma arm.

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. The 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: The investigators 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, the investigators 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 the investigators will test 100 patients with and glaucoma and 60 normals each eight times. In addition, the investigators are retesting 50 subjects once a week for 5 weeks. The investigators 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. The investigators 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 to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01051739

Locations
United States, Iowa
Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, United States, 52246-2208
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Michael Wall, MD Iowa City VA Health Care System, Iowa City, IA
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01051739     History of Changes
Other Study ID Numbers: C7098-R
Study First Received: January 15, 2010
Results First Received: October 25, 2016
Last Updated: February 13, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by VA Office of Research and Development:
vision testing
perimetry
glaucoma
test variability

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on June 22, 2017