Assessment of Ability Related to Vision

NCT01027312

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Glaucoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- All patients 18 yrs of age and older

- must understand and respond to spoken English and be fully literate.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title Assessment of Ability Related to Vision
Official Title Reproducibility and Clinical Usefulness of AARV (Assessment of Ability Related to Vision)
Brief 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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population One hundred patients with bilateral unstable glaucoma and twenty patients who appear to be normal will be enrolled.
Condition Glaucoma
Intervention Not Provided
Study 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.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 4, 2009)
121
Original Actual Enrollment Same as current
Actual Study Completion Date August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01027312
Other Study ID Numbers IRB#07-842
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD:Yes
Plan Description:A manuscript has been written and published
Responsible Party George L. Spaeth MD, Wills Eye
Study Sponsor Wills Eye
Collaborators Pfizer
Investigators
Principal Investigator:George L Spaeth, MDWills Eye Institute
PRS Account Wills Eye
Verification Date November 2016