GlaucomaAARVNCT01027312
Assessment of Ability Related to Vision
An observational study of Glaucoma, run by Wills Eye.
Trial summary
To determine the clinical usefulness of a refined third-generation instrument - The Assessment of Ability Related to Vision (AARV) in establishing the amount of disability, charting the detrimental effects of progressive disease and establishing the beneficial effects of treatment Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- How many people
- 121 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: One hundred patients with bilateral unstable glaucoma and twenty patients who appear to be normal will be enrolled.
Who may be able to join
- All patients 18 yrs of age and older
- must understand and respond to spoken English and be fully literate.
Who cannot join
- Patients with significant neurological problems (like Parkinson's disease), motor problems (like arthritis) or other significant illnesses that may prevent them from completing the testing involved in the study (like advanced heart failure).
- Patients who have received training related to low vision.
About this study
Official title: Reproducibility and Clinical Usefulness of AARV (Assessment of Ability Related to Vision)
To determine the clinical usefulness of a refined third-generation instrument - The Assessment of Ability Related to Vision (AARV) in establishing the amount of disability, charting the detrimental effects of progressive disease and establishing the beneficial effects of treatment
Read the detailed description
This research study is designed to test the usefulness and repeatability of testing how much disability is caused by vision loss due to glaucoma. We are recruiting 100 patients with glaucoma and 20 healthy (have no eye disease) individuals to be enrolled in this study. The healthy study participants will be enrolled in order to describe how a healthy individual will perform on the test designed to assess one's performance when completing ten activities of daily living.
Clinical testing will be conducted by binocular and monocular visual fields, contrast sensitivity and visual acuity. The NEI-VFQ 15 Quality of Life Questionnaire will be used to measure patients perception of how well they are doing.
- Conditions
- Glaucoma
- Keywords
- Glaucoma, quality of life, daily living activities, visual fields, contrast sensitivity
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma Patients | Glaucoma patients covering the entire range of visual field loss from none to advanced. | |
| Control Group | Aged matched people with no eye diseases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the reproducibility of AARV, and its relationship to standard clinical tests
Measured: Day 1, 1 week, 6 months, 1 year
Secondary outcomes (1)
A better estimate of the reproducibility of standard clinical tests.
Measured: Day 1, 1 week, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2009 (estimated)
- Study startFeb 2008
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, George L. Spaeth MD, Wills Eye
- Investigators
- George L Spaeth, MD, Principal investigator, Wills Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027312
- Sponsor's protocol ID
- IRB#07-842
- Acronym
- AARV
- Status last verified
- Nov 2016
- First submitted
- 4 Dec 2009
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: A manuscript has been written and published
Publications
Wei H, Sawchyn AK, Myers JS, Katz LJ, Moster MR, Wizov SS, Steele M, Lo D, Spaeth GL. A clinical method to assess the effect of visual loss on the ability to perform activities of daily living. Br J Ophthalmol. 2012 May;96(5):735-41. doi: 10.1136/bjophthalmol-2011-300093. Epub 2012 Jan 12.
PubMed 22241927
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility and Clinical Usefulness of AARV (Assessment of Ability Related to Vision)
- ClinicalTrials.gov ID
- NCT01027312
- Acronym / sponsor ID
- AARV / IRB#07-842
- Conditions
- Glaucoma
- Keywords
- Glaucoma, quality of life, daily living activities, visual fields, contrast sensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Feb 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 7 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the clinical usefulness of a refined third-generation instrument - The Assessment of Ability Related to Vision (AARV) in establishing the amount of disability, charting the detrimental effects of progressive disease and establishing the beneficial effects of treatment
Detailed description
This research study is designed to test the usefulness and repeatability of testing how much disability is caused by vision loss due to glaucoma. We are recruiting 100 patients with glaucoma and 20 healthy (have no eye disease) individuals to be enrolled in this study. The healthy study participants will be enrolled in order to describe how a healthy individual will perform on the test designed to assess one's performance when completing ten activities of daily living.
Clinical testing will be conducted by binocular and monocular visual fields, contrast sensitivity and visual acuity. The NEI-VFQ 15 Quality of Life Questionnaire will be used to measure patients perception of how well they are doing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glaucoma Patients | – | –Glaucoma patients covering the entire range of visual field loss from none to advanced. |
| Control Group | – | –Aged matched people with no eye diseases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- One hundred patients with bilateral unstable glaucoma and twenty patients who appear to be normal will be enrolled.
Key inclusion criteria (2 listed)
- All patients 18 yrs of age and older
- must understand and respond to spoken English and be fully literate.
Key exclusion criteria (2 listed)
- Patients with significant neurological problems (like Parkinson's disease), motor problems (like arthritis) or other significant illnesses that may prevent them from completing the testing involved in the study (like advanced heart failure).
- Patients who have received training related to low vision.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the reproducibility of AARV, and its relationship to standard clinical tests
Time frame: Day 1, 1 week, 6 months, 1 year
1 secondary outcome
A better estimate of the reproducibility of standard clinical tests.
Time frame: Day 1, 1 week, 6 months, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
- Results publication: PubMed 22241927Wei H, Sawchyn AK, Myers JS, Katz LJ, Moster MR, Wizov SS, Steele M, Lo D, Spaeth GL. A clinical method to assess the effect of visual loss on the ability to perform activities of daily living. Br J Ophthalmol. 2012 May;96(5):735-41. doi: 10.1136/bjophthalmol-2011-300093. Epub 2012 Jan 12.
- Individual participant dataSharing planned: Yes. A manuscript has been written and published
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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.
George L Spaeth, MD principal investigator
Wills Eye Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by Wills Eye.
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 2 inclusion and 2 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 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the reproducibility of AARV, and its relationship to standard clinical tests (time frame: Day 1, 1 week, 6 months, 1 year). 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 NCT01027312, which also lists 1 linked publication.
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 22 Nov 2016.