Variability in Perimetry Study

NCT01051739 | Completed Results

• 1 other identifier: C7098-R
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glaucoma

Keywords

vision testing; perimetry; glaucoma; test variability

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Progressing in Each Group Using Pointwise Linear Regression

  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.

  4 years

Study Arms (2)

Group 1

glaucoma

Procedure: Comparison of four visual field testing strategies

Group 2

normal

Procedure: Comparison of four visual field testing strategies

Interventions

Comparison of four visual field testing strategies PROCEDURE

We compared the ability of four perimetric strategies to detect visual field change in the glaucoma arm.

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Iowa City VA Health Care System, Iowa City, IA

Iowa City, Iowa, 52246-2208, United States

Location

Related Publications (3)

• Wall M, Doyle CK, Eden T, Zamba KD, Johnson CA. Size threshold perimetry performs as well as conventional automated perimetry with stimulus sizes III, V, and VI for glaucomatous loss. Invest Ophthalmol Vis Sci. 2013 Jun 7;54(6):3975-83. doi: 10.1167/iovs.12-11300.

  PMID: 23633660 BACKGROUND

• Kummet CM, Zamba KD, Doyle CK, Johnson CA, Wall M. Refinement of pointwise linear regression criteria for determining glaucoma progression. Invest Ophthalmol Vis Sci. 2013 Sep 19;54(9):6234-41. doi: 10.1167/iovs.13-11680.

  PMID: 23908183 BACKGROUND

• Wall M, Doyle CK, Zamba KD, Artes P, Johnson CA. The repeatability of mean defect with size III and size V standard automated perimetry. Invest Ophthalmol Vis Sci. 2013 Feb 15;54(2):1345-51. doi: 10.1167/iovs.12-10299.

  PMID: 23341012 RESULT

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Limitations and Caveats

not all subjects completed the study (dropouts).

Results Point of Contact

• Title: Michael Wall, M.D.
• Organization: Iowa City Veterans Administration Medical Center

michael-wall@uiowa.edu

319-3380581

Study Officials

• Michael Wall, MD

  Iowa City VA Health Care System, Iowa City, IA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2010
• First Posted: January 20, 2010
• Study Start: July 1, 2010
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 21, 2017
• Results First Posted: February 10, 2017

Record last verified: 2017-02

Locations

US (1)