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Assessment of Ability Related to Vision (AARV)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01027312
First Posted: December 7, 2009
Last Update Posted: November 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
George L. Spaeth MD, Wills Eye
December 4, 2009
December 7, 2009
November 22, 2016
February 2008
August 2010   (Final data collection date for primary outcome measure)
the reproducibility of AARV, and its relationship to standard clinical tests [ Time Frame: Day 1, 1 week, 6 months, 1 year ]
Same as current
Complete list of historical versions of study NCT01027312 on ClinicalTrials.gov Archive Site
A better estimate of the reproducibility of standard clinical tests. [ Time Frame: Day 1, 1 week, 6 months, 1 year ]
Same as current
Not Provided
Not Provided
 
Assessment of Ability Related to Vision
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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
One hundred patients with bilateral unstable glaucoma and twenty patients who appear to be normal will be enrolled.
Glaucoma
Not Provided
  • 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.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
121
August 2010
August 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients 18 yrs of age and older
  • must understand and respond to spoken English and be fully literate.

Exclusion Criteria:

  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01027312
IRB#07-842
No
Not Provided
Plan to Share IPD: Yes
Plan Description: A manuscript has been written and published
George L. Spaeth MD, Wills Eye
Wills Eye
Pfizer
Principal Investigator: George L Spaeth, MD Wills Eye Institute
Wills Eye
November 2016