Assessment of Ability Related to Vision

Glaucoma Clinical Trial

— AARV  

Official title:

Reproducibility and Clinical Usefulness of AARV (Assessment of Ability Related to Vision)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01027312
• Other study ID #: IRB#07-842
• Status: Completed
• Phase: N/A
• First received: December 4, 2009
• Last updated: November 19, 2016
• Start date: February 2008
• Est. completion date: August 2010

Study information

• Verified date: November 2016
• Source: Wills Eye
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wills Eye	Pfizer

References & Publications (1)

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/bjophtha — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the reproducibility of AARV, and its relationship to standard clinical tests		Day 1, 1 week, 6 months, 1 year	No
Secondary	A better estimate of the reproducibility of standard clinical tests.		Day 1, 1 week, 6 months, 1 year	No