Variability in Perimetry Study

Visual Field Clinical Trial

— VIP II  

Official title:

Improved Assessment of Visual Field Change

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01051739
• Other study ID #: C7098-R
• Status: Completed
• Phase: N/A
• First received: January 15, 2010
• Last updated: February 4, 2016
• Start date: July 2010
• Est. completion date: September 2015

Study information

• Verified date: February 2016
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Visual Field

Locations

Country	Name	City	State
United States	Iowa City VA Health Care System, Iowa City, IA	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to significant visual field change	Perimetric method that most efficiently detects visual field change.	4 years	No