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Assessment of Ability Related to Vision (AARV)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
George L. Spaeth MD, Wills Eye
ClinicalTrials.gov Identifier:
NCT01027312
First received: December 4, 2009
Last updated: November 21, 2011
Last verified: November 2011
History of Changes

December 4, 2009
November 21, 2011
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Same as current
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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
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  • 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.
Not Provided

*   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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01027312
IRB#07-842
No
George L. Spaeth MD, Wills Eye
Wills Eye
Pfizer
Principal Investigator: George L Spaeth, MD Wills Eye Institute
Wills Eye
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP