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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
  Purpose

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


Condition
Glaucoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reproducibility and Clinical Usefulness of AARV (Assessment of Ability Related to Vision)

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by Wills Eye:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 121
Study Start Date: February 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

One hundred patients with bilateral unstable glaucoma and twenty patients who appear to be normal will be enrolled.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01027312

Sponsors and Collaborators
Wills Eye
Pfizer
Investigators
Principal Investigator: George L Spaeth, MD Wills Eye Institute
  More Information

No publications provided

Responsible Party: George L. Spaeth MD, Principal Investigator, Wills Eye
ClinicalTrials.gov Identifier: NCT01027312     History of Changes
Other Study ID Numbers: IRB#07-842
Study First Received: December 4, 2009
Last Updated: November 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Wills Eye:
Glaucoma
quality of life
daily living activities
visual fields
contrast sensitivity

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013