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Adult Trials: 18+ Years
- All patients 18 yrs of age and older
- must understand and respond to spoken English and be fully literate.
- 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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| 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 |
| ||||
| 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 | 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:
Exclusion Criteria:
| ||||
| Sex/Gender |
| ||||
| 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 |
| ||||
| Responsible Party | George L. Spaeth MD, Wills Eye | ||||
| Study Sponsor | Wills Eye | ||||
| Collaborators | Pfizer | ||||
| Investigators |
| ||||
| PRS Account | Wills Eye | ||||
| Verification Date | November 2016 | ||||