Assessment of Ability Related to Vision | NCT01027312

Studies
Assessment of Ability Related to Vision

NCT01027312

Sponsor

Wills Eye

Status

Completed

Last Update Posted

Nov 22, 2016Estimated

Enrollment

121Actual

Phase

Not provided

Conditions

Glaucoma

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Aug 2010Actual

Completion Date

Aug 2010Actual

First Submitted Date

Dec 4, 2009

First Submission Date that Met QC Criteria

Dec 4, 2009

First Posted Date

Dec 7, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2016

Last Update Posted Date

Nov 22, 2016Estimated

Name	Class
Pfizer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

121Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the reproducibility of AARV, and its relationship to standard clinical tests		Day 1, 1 week, 6 months, 1 year

Secondary Outcomes

Measure	Description	Time Frame
A better estimate of the reproducibility of standard clinical tests.		Day 1, 1 week, 6 months, 1 year

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
George L Spaeth, MD	Wills Eye Institute	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22241927	Result	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.

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases