GlaucomaVIPIINCT01051739
Variability in Perimetry Study
An observational study of Glaucoma, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Comparison of four visual field testing strategies
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Sep 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: glaucoma patient with 0 to -25 dB mean deviation and normal subjects
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, 52246-2208
About this study
Official title: Improved Assessment of Visual Field Change
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.
Read the 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.
- Conditions
- Glaucoma
- Being tested
- Comparison of four visual field testing strategies
- Keywords
- vision testing, perimetry, glaucoma, test variability
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of four visual field testing strategiesProcedure or surgery
We compared the ability of four perimetric strategies to detect visual field change in the glaucoma arm.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | glaucoma Receives: Procedure: Comparison of four visual field testing strategies | |
| Group 2 | normal Receives: Procedure: Comparison of four visual field testing strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startJul 2010
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Michael Wall, MD, Principal investigator, Iowa City VA Health Care System, Iowa City, IA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01051739
- Sponsor's protocol ID
- C7098-R
- Acronym
- VIPII
- Status last verified
- Feb 2017
- First submitted
- 15 Jan 2010
- Last updated
- 21 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23633660Kummet 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.
PubMed 23908183Wall 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.
PubMed 23341012
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Assessment of Visual Field Change
- ClinicalTrials.gov ID
- NCT01051739
- Acronym / sponsor ID
- VIPII / C7098-R
- Conditions
- Glaucoma
- Keywords
- vision testing, perimetry, glaucoma, test variability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jul 2010
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 20 Jan 2010 (estimated)
- Results
- Posted 10 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Comparison of four visual field testing strategiesglaucoma |
| Group 2 | – | Procedure: Comparison of four visual field testing strategiesnormal |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- glaucoma patient with 0 to -25 dB mean deviation and normal subjects
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparison of four visual field testing strategiesWe compared the ability of four perimetric strategies to detect visual field change in the glaucoma arm. | Procedure or surgery | Group 1, Group 2 |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23633660Wall 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.
- Background: PubMed 23908183Kummet 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.
- Results publication: PubMed 23341012Wall 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.
- Individual participant dataSharing planned: Undecided
Related trials for Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Not yet recruitingPhase 2
VGFTe-(HD)-OD-2566: Adjunctive Aflibercept Ahmed Glaucoma Valve (AAA) Study
Glaucoma
Not yet recruitingPhase 4
Iopidine to Decrease Intraocular Pressure Rise After Injections
Macular Degeneration, Diabetic Retinopathy
Recruiting
Timing of Glaucoma Drainage Device With Boston Keratoprosthesis
Corneal Transplantation, Glaucoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Wall, MD principal investigator
Iowa City VA Health Care System, Iowa City, IA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Progressing in Each Group Using Pointwise Linear Regression (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01051739, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2017.