AMD Clinical Trial
— AMDOfficial title:
A Randomized Controlled Trial of Eccentric Viewing Training vs. Closed Circuit Television Use for Visual Rehabilitation From Age-Related Macular Degeneration
Verified date | September 2012 |
Source | Lawson Health Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
Patients with advanced Age-Related Macular Degeneration will be randomized into one of two treatment groups. One group will receive eccentric view (EV) training while the other a closed circuit television (CCTV) training for 6 weeks. Reading speed and accuracy will be assessed pre- and post- treatment to determine if one treatment is superior to the other.
Status | Completed |
Enrollment | 10 |
Est. completion date | September 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - First time AMD patient sent to CNIB for visual rehabilitation - Macular Degeneration reducing visual acuity (VA) to between 20/160 and 20/400 (ETDRS scale) - Over the age of 50 years - English as the first language and able to read Exclusion Criteria: - Expected anti-VEGF or Visudyne treatment over the course of the study - Individuals who do not have reading as a life goal - Mental cognition that makes learning the specific rehabilitation tasks unlikely (determined by mini-mental state exam) - Any other ocular pathology that can reduce central vision including cornea decompensation (scar or thickness), cataract (grade III or more for each type of cataract), vitritis (2+ or more) or advanced glaucoma (C/D ratio of >0.7) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Canada | CNIB, Toronto Branch | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome measures reading speed for 1.3M print (in correct words per minute). | 6 weeks intervention | No | |
Secondary | The secondary outcomes measures 1. Reading accuracy for 1.3M; | 6 weeks intervention | No | |
Secondary | 2. Reading speed and accuracy for 1M | 6 weeks intervention | No | |
Secondary | 3. Reading performance tests. | 6 week's intervention | No | |
Secondary | 4. Reading Behavior Inventory | 6 week's intervention | No | |
Secondary | 5. VFQ-25 plus 2 extra questions). | 6 week's intervention | No | |
Secondary | 6. Geriatric depression scale | 6 week | No |
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